Comparing the effectiveness of Tofacitinib (Alpamont) and Adalimumab (CinnoRa) on nail lesions’ treatment in patients with Psoriatic Arthritis: A clinical trial study
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Protocol summary
Randomized, parallel-group, open-label Phase 3 clinical trial involving 150 psoriatic arthritis patients with nail involvement. Participants will be randomly assigned (1:1) using block randomization with variable block sizes (4, 6, 8).
Randomized, parallel-group, open-label Phase 3 clinical trial involving 70 psoriatic arthritis patients with nail involvement. Participants will be randomly assigned (1:1) using block randomization with variable block sizes (4, 6, 8).
Randomized, parallel-group, open-label Phase 3 clinical trial involving 15070 psoriatic arthritis patients with nail involvement. Participants will be randomly assigned (1:1) using block randomization with variable block sizes (4, 6, 8).
کارآزمایی بالینی فاز ۳، تصادفی‌شده، با گروه‌های موازی و بدون کورسازی، شامل ۱۵۰ بیمار مبتلا به آرتریت پسوریاتیک با درگیری ناخن. تخصیص بیماران به دو گروه مداخله با نسبت ۱:۱ و به روش بلوک‌های تصادفی با اندازه‌های متغیر (۴، ۶ و ۸) انجام می‌شود.
کارآزمایی بالینی فاز ۳، تصادفی‌شده، با گروه‌های موازی و بدون کورسازی، شامل 70 بیمار مبتلا به آرتریت پسوریاتیک با درگیری ناخن. تخصیص بیماران به دو گروه مداخله با نسبت ۱:۱ و به روش بلوک‌های تصادفی با اندازه‌های متغیر (۴، ۶ و ۸) انجام می‌شود.
کارآزمایی بالینی فاز ۳، تصادفی‌شده، با گروه‌های موازی و بدون کورسازی، شامل ۱۵۰70 بیمار مبتلا به آرتریت پسوریاتیک با درگیری ناخن. تخصیص بیماران به دو گروه مداخله با نسبت ۱:۱ و به روش بلوک‌های تصادفی با اندازه‌های متغیر (۴، ۶ و ۸) انجام می‌شود.
The study is conducted at the Rheumatology Clinic of Ahvaz Jundishapur University of Medical Sciences. Patients are randomly assigned to receive tofacitinib (50 mg tablets, every two weeks) or adalimumab (40 mg injections, every two weeks) for 12 weeks. Clinical assessments are performed at weeks 0, 4, 8, and 12 using the NAPSI and Lesion Quadrant indices. Blinding is not implemented.
The study is conducted at the Rheumatology Clinic of Ahvaz Jundishapur University of Medical Sciences. Patients are randomly assigned to receive tofacitinib (5 mg tablets, every two weeks) or adalimumab (40 mg injections, every two weeks) for 12 weeks. Clinical assessments are performed at weeks 0, 8, and 12 using the NAPSI and Lesion Quadrant indices. Blinding is not implemented.
The study is conducted at the Rheumatology Clinic of Ahvaz Jundishapur University of Medical Sciences. Patients are randomly assigned to receive tofacitinib (505 mg tablets, every two weeks) or adalimumab (40 mg injections, every two weeks) for 12 weeks. Clinical assessments are performed at weeks 0, 4, 8, and 12 using the NAPSI and Lesion Quadrant indices. Blinding is not implemented.
مطالعه در کلینیک روماتولوژی دانشگاه علوم پزشکی جندی‌شاپور اهواز انجام می‌شود. بیماران به‌صورت تصادفی به دریافت توفاسیتینیب (قرص ۵۰ میلی‌گرم، هر دو هفته یک‌بار) یا آدالیمومب (آمپول ۴۰ میلی‌گرم، هر دو هفته یک‌بار) به مدت ۱۲ هفته تخصیص می‌یابند. ارزیابی‌های بالینی در هفته‌های ۰، ۴، ۸ و ۱۲ با استفاده از شاخص‌های NAPSI و Lesion Quadrant انجام می‌شود. کورسازی انجام نمی‌شود.
مطالعه در کلینیک روماتولوژی دانشگاه علوم پزشکی جندی‌شاپور اهواز انجام می‌شود. بیماران به‌صورت تصادفی به دریافت توفاسیتینیب (قرص 5 میلی‌گرم، هر دو هفته یک‌بار) یا آدالیمومب (آمپول ۴۰ میلی‌گرم، هر دو هفته یک‌بار) به مدت ۱۲ هفته تخصیص می‌یابند. ارزیابی‌های بالینی در هفته‌های ۰، ۸ و ۱۲ با استفاده از شاخص‌های NAPSI و Lesion Quadrant انجام می‌شود. کورسازی انجام نمی‌شود.
مطالعه در کلینیک روماتولوژی دانشگاه علوم پزشکی جندی‌شاپور اهواز انجام می‌شود. بیماران به‌صورت تصادفی به دریافت توفاسیتینیب (قرص ۵۰5 میلی‌گرم، هر دو هفته یک‌بار) یا آدالیمومب (آمپول ۴۰ میلی‌گرم، هر دو هفته یک‌بار) به مدت ۱۲ هفته تخصیص می‌یابند. ارزیابی‌های بالینی در هفته‌های ۰، ۴، ۸ و ۱۲ با استفاده از شاخص‌های NAPSI و Lesion Quadrant انجام می‌شود. کورسازی انجام نمی‌شود.
Group 1 (Tofacitinib): 50 mg tofacitinib tablets (Aburaihan Pharmaceutical Company), orally every two weeks for 12 weeks.
Group 2 (Adalimumab): 40 mg adalimumab injections (SinaGen Pharmaceutical Company), subcutaneously every two weeks for 12 weeks.
Group 1 (Tofacitinib): 5 mg tofacitinib tablets (Aburaihan Pharmaceutical Company), orally every two weeks for 12 weeks.
Group 2 (Adalimumab): 40 mg adalimumab injections (SinaGen Pharmaceutical Company), subcutaneously every two weeks for 12 weeks.
Group 1 (Tofacitinib): 505 mg tofacitinib tablets (Aburaihan Pharmaceutical Company), orally every two weeks for 12 weeks. Group 2 (Adalimumab): 40 mg adalimumab injections (SinaGen Pharmaceutical Company), subcutaneously every two weeks for 12 weeks.
گروه اول (توفاسیتینیب): قرص ۵۰ میلی‌گرم توفاسیتینیب (شرکت داروسازی ابوریحان)، خوراکی، هر دو هفته یک‌بار به مدت ۱۲ هفته.
گروه دوم (آدالیمومب): آمپول ۴۰ میلی‌گرم آدالیمومب (شرکت داروسازی سیناژن)، زیرجلدی، هر دو هفته یک‌بار به مدت ۱۲ هفته.
گروه اول (توفاسیتینیب): قرص 5 میلی‌گرم توفاسیتینیب (شرکت داروسازی ابوریحان)، خوراکی، هر دو هفته یک‌بار به مدت ۱۲ هفته.
گروه دوم (آدالیمومب): آمپول ۴۰ میلی‌گرم آدالیمومب (شرکت داروسازی سیناژن)، زیرجلدی، هر دو هفته یک‌بار به مدت ۱۲ هفته.
گروه اول (توفاسیتینیب): قرص ۵۰5 میلی‌گرم توفاسیتینیب (شرکت داروسازی ابوریحان)، خوراکی، هر دو هفته یک‌بار به مدت ۱۲ هفته. گروه دوم (آدالیمومب): آمپول ۴۰ میلی‌گرم آدالیمومب (شرکت داروسازی سیناژن)، زیرجلدی، هر دو هفته یک‌بار به مدت ۱۲ هفته.
General information
150
70
15070
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Please be informed that the outcome assessment time points have been revised from baseline, week 4, week 8, and week 12 to baseline, week 8, and week 12. In addition, the sample size has been revised to 70 participants. All changes were made in consultation with a biostatistics specialist; therefore, the clinical trial registration has been updated accordingly.
Please be informed that the outcome assessment time points have been revised from baseline, week 4, week 8, and week 12 to baseline, week 8, and week 12. In addition, the sample size has been revised to 70 participants. All changes were made in consultation with a biostatistics specialist; therefore, the clinical trial registration has been updated accordingly.
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با سلام و احترام. با توجه به اینکه زمان های اندازه گیری پیامد از زمان شروع مطالعه، هفته چهار، هفته هشتم و هفته داوزدهم به زمان شروع مطالعه، هفته هشتم و هفته داوزدهم تغییر یافت. همچنین حجم نمونه به 70 نفر تغییر یافت. تمام تغییرات با نظر متخصص آمار زیستی انجام و لذا ثبت کارآزمائی بالینی بروزرسانی شد.
با سلام و احترام. با توجه به اینکه زمان های اندازه گیری پیامد از زمان شروع مطالعه، هفته چهار، هفته هشتم و هفته داوزدهم به زمان شروع مطالعه، هفته هشتم و هفته داوزدهم تغییر یافت. همچنین حجم نمونه به 70 نفر تغییر یافت. تمام تغییرات با نظر متخصص آمار زیستی انجام و لذا ثبت کارآزمائی بالینی بروزرسانی شد.
Primary outcomes
#1
At baseline (week 0) and at weeks 4, 8, and 12 after treatment initiation.
At baseline (week 0) and at weeks 8, and 12 after treatment initiation.
At baseline (week 0) and at weeks 4, 8, and 12 after treatment initiation.
در ابتدای مطالعه (هفته ۰) و در هفته‌های ۴، ۸ و ۱۲ پس از شروع درمان.
در ابتدای مطالعه (هفته ۰) و در هفته‌های ۸ و ۱۲ پس از شروع درمان.
در ابتدای مطالعه (هفته ۰) و در هفته‌های ۴، ۸ و ۱۲ پس از شروع درمان.
Secondary outcomes
#1
Baseline (prior to initiation of treatment), Week 4, Week 8 after treatment initiation, and Week 12 (end of treatment period).
Baseline (prior to initiation of treatment), Week Week 8 after treatment initiation, and Week 12 (end of treatment period).
Baseline (prior to initiation of treatment), Week 4, Week 8 after treatment initiation, and Week 12 (end of treatment period).
ابتدای مطالعه (پیش از شروع مداخله درمانی)، هفته چهارم، هفته هشتم پس از شروع درمان و هفته دوازدهم (پایان دوره درمان)
ابتدای مطالعه (پیش از شروع مداخله درمانی)، هفته هشتم پس از شروع درمان و هفته دوازدهم (پایان دوره درمان)
ابتدای مطالعه (پیش از شروع مداخله درمانی)، هفته چهارم، هفته هشتم پس از شروع درمان و هفته دوازدهم (پایان دوره درمان)
Intervention groups
#1
Intervention group: First Group (Tofacitinib): 50 mg oral tofacitinib tablets (brand name "Urositra," manufactured by Sobhan Darou Pharmaceutical Co., Iran) administered orally once every two weeks for a duration of 12 weeks, under treatment and evaluation.
Intervention group: First Group (Tofacitinib): 5 mg oral tofacitinib tablets (brand name "Urositra," manufactured by Sobhan Darou Pharmaceutical Co., Iran) administered orally once every two weeks for a duration of 12 weeks, under treatment and evaluation.
Intervention group: First Group (Tofacitinib): 505 mg oral tofacitinib tablets (brand name "Urositra," manufactured by Sobhan Darou Pharmaceutical Co., Iran) administered orally once every two weeks for a duration of 12 weeks, under treatment and evaluation.
گروه مداخله: گروه اول (توفاسیتینیب):قرص ۵۰ میلی‌گرم توفاسیتینیب (با نام تجاری «اوروسیترا» تولید شرکت داروسازی سبحان دارو، ایران) به صورت خوراکی، هر دو هفته یک‌بار به مدت ۱۲ هفته تحت درمان و ارزیابی قرار می‌گیرند.
گروه مداخله: گروه اول (توفاسیتینیب): قرص ۵ میلی‌گرم توفاسیتینیب (با نام تجاری «اوروسیترا» تولید شرکت داروسازی سبحان دارو، ایران) به صورت خوراکی، هر دو هفته یک‌بار به مدت ۱۲ هفته تحت درمان و ارزیابی قرار می‌گیرند.
گروه مداخله: گروه اول (توفاسیتینیب):قرص ۵۰ میلی‌گرم توفاسیتینیب (با نام تجاری «اوروسیترا» تولید شرکت داروسازی سبحان دارو، ایران) به صورت خوراکی، هر دو هفته یک‌بار به مدت ۱۲ هفته تحت درمان و ارزیابی قرار می‌گیرند.
#2
گروه مداخله: گروه دوم (آدالیمومب):آمپول ۴۰ میلی‌گرم آدالیمومب (با نام تجاری «Humira» تولید شرکت AbbVie) به صورت زیرجلدی، هر دو هفته یک‌بار به مدت ۱۲ هفته تحت درمان و ارزیابی قرار می‌گیرند.
گروه مداخله: گروه دوم (آدالیمومب): آمپول ۴۰ میلی‌گرم آدالیمومب (با نام تجاری «Humira» تولید شرکت AbbVie) به صورت زیرجلدی، هر دو هفته یک‌بار به مدت ۱۲ هفته تحت درمان و ارزیابی قرار می‌گیرند.
گروه مداخله: گروه دوم (آدالیمومب):آمپول ۴۰ میلی‌گرم آدالیمومب (با نام تجاری «Humira» تولید شرکت AbbVie) به صورت زیرجلدی، هر دو هفته یک‌بار به مدت ۱۲ هفته تحت درمان و ارزیابی قرار می‌گیرند.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abdollah Rafiei
Full name of responsible person - Persian: عبدالله رفیعی
Street address - English: Jundishapur University of Ahvaz, Golestan Highway
Street address - Persian: اتوبان گلستان-دانشگاه علوم پزشکی جندی شاپور اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Fax:
Email: rahmani-ah@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Abdollah Rafiei
Full name of responsible person - Persian: عبدالله رفیعی
Street address - English: Jundishapur University of Ahvaz, Golestan Highway
Street address - Persian: اتوبان گلستان-دانشگاه علوم پزشکی جندی شاپور اهواز
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Fax:
Email: rafiei-a@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Abdollah Rafiei Full name of responsible person - Persian: عبدالله رفیعی Street address - English: Jundishapur University of Ahvaz, Golestan Highway Street address - Persian: اتوبان گلستان-دانشگاه علوم پزشکی جندی شاپور اهواز City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3311 6515 Fax: Email: rahmanirafiei-aha@ajums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aliakbar Gorjipour
Full name of responsible person - Persian: علی اکبر گرجی پور
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golestan Highway, Jundishapur University of Medical Sciences and Health Services, Ahvaz
Street address - Persian: بزرگراه گلستان، دانشگاه علوم پزشکی و خدمات درمانی جندی شاپور اهواز
City - English: Khouzestan
City - Persian: خوزستان
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Mobile: +98 917 142 1189
Fax:
Email: Aligorji3335@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aliakbar Gorjipour
Full name of responsible person - Persian: علی اکبر گرجی پور
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golestan Highway
Street address - Persian: بزرگراه گلستان
City - English: Khouzestan
City - Persian: خوزستان
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Mobile: +98 917 142 1189
Fax:
Email: Aligorji3335@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Aliakbar Gorjipour Full name of responsible person - Persian: علی اکبر گرجی پور Position - English: Resident Position - Persian: رزیدنت Latest degree: specialist Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Golestan Highway, Jundishapur University of Medical Sciences and Health Services, Ahvaz Street address - Persian: بزرگراه گلستان، دانشگاه علوم پزشکی و خدمات درمانی جندی شاپور اهواز City - English: Khouzestan City - Persian: خوزستان Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3311 6515 Mobile: +98 917 142 1189 Fax: Email: Aligorji3335@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aliakbar Gorjipour
Full name of responsible person - Persian: علی اکبر گرجی پور
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golestan Highway, Jundishapur University of Medical Sciences and Health Services, Ahvaz
Street address - Persian: بزرگراه گلستان، دانشگاه علوم پزشکی و خدمات درمانی جندی شاپور اهواز
City - English: Khouzestan
City - Persian: خوزستان
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Mobile: +98 917 142 1189
Fax:
Email: Aligorji3335@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aliakbar Gorjipour
Full name of responsible person - Persian: علی اکبر گرجی پور
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golestan Highway
Street address - Persian: بزرگراه گلستان
City - English: Khouzestan
City - Persian: خوزستان
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Mobile: +98 917 142 1189
Fax:
Email: Aligorji3335@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Aliakbar Gorjipour Full name of responsible person - Persian: علی اکبر گرجی پور Position - English: Resident Position - Persian: رزیدنت Latest degree: specialist Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Golestan Highway, Jundishapur University of Medical Sciences and Health Services, Ahvaz Street address - Persian: بزرگراه گلستان، دانشگاه علوم پزشکی و خدمات درمانی جندی شاپور اهواز City - English: Khouzestan City - Persian: خوزستان Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3311 6515 Mobile: +98 917 142 1189 Fax: Email: Aligorji3335@gmail.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aliakbar Gorjipour
Full name of responsible person - Persian: علی اکبر گرجی پور
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golestan Highway, Jundishapur University of Medical Sciences and Health Services, Ahvaz
Street address - Persian: بزرگراه گلستان، دانشگاه علوم پزشکی و خدمات درمانی جندی شاپور اهواز
City - English: Khouzestan
City - Persian: خوزستان
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Mobile: +98 917 142 1189
Fax:
Email: Aligorji3335@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Aliakbar Gorjipour
Full name of responsible person - Persian: علی اکبر گرجی پور
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Golestan Highway
Street address - Persian: بزرگراه گلستان
City - English: Khouzestan
City - Persian: خوزستان
Province: Khouzestan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3311 6515
Mobile: +98 917 142 1189
Fax:
Email: Aligorji3335@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Aliakbar Gorjipour Full name of responsible person - Persian: علی اکبر گرجی پور Position - English: Resident Position - Persian: رزیدنت Latest degree: specialist Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Golestan Highway, Jundishapur University of Medical Sciences and Health Services, Ahvaz Street address - Persian: بزرگراه گلستان، دانشگاه علوم پزشکی و خدمات درمانی جندی شاپور اهواز City - English: Khouzestan City - Persian: خوزستان Province: Khouzestan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3311 6515 Mobile: +98 917 142 1189 Fax: Email: Aligorji3335@gmail.com Web page address:
Protocol summary
Study aim
To evaluate the efficacy and safety of tofacitinib versus adalimumab in treating nail, joint, and skin involvement in psoriatic arthritis patients.
Design
Randomized, parallel-group, open-label Phase 3 clinical trial involving 70 psoriatic arthritis patients with nail involvement. Participants will be randomly assigned (1:1) using block randomization with variable block sizes (4, 6, 8).
Settings and conduct
The study is conducted at the Rheumatology Clinic of Ahvaz Jundishapur University of Medical Sciences. Patients are randomly assigned to receive tofacitinib (5 mg tablets, every two weeks) or adalimumab (40 mg injections, every two weeks) for 12 weeks. Clinical assessments are performed at weeks 0, 8, and 12 using the NAPSI and Lesion Quadrant indices. Blinding is not implemented.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of psoriatic arthritis per CASPAR criteria confirmed by a rheumatologist and a dermatologist; nail involvement; prior use of disease-modifying antirheumatic drugs (DMARDs).
Exclusion Criteria: History of hypersensitivity to study drugs; severe infections or concurrent malignancies; pregnancy or breastfeeding; other rheumatologic diseases; fungal or infectious nail diseases; history of deep vein thrombosis (DVT); cardiovascular diseases; smoking.
Intervention groups
Group 1 (Tofacitinib): 5 mg tofacitinib tablets (Aburaihan Pharmaceutical Company), orally every two weeks for 12 weeks.
Group 2 (Adalimumab): 40 mg adalimumab injections (SinaGen Pharmaceutical Company), subcutaneously every two weeks for 12 weeks.
Main outcome variables
Primary outcomes: Changes in Nail Psoriasis Severity Index (NAPSI) and Lesion Quadrant Index from baseline to week 12.
General information
Reason for update
Please be informed that the outcome assessment time points have been revised from baseline, week 4, week 8, and week 12 to baseline, week 8, and week 12. In addition, the sample size has been revised to 70 participants. All changes were made in consultation with a biostatistics specialist; therefore, the clinical trial registration has been updated accordingly.
Acronym
IRCT registration information
IRCT registration number:IRCT20250503065587N1
Registration date:2025-05-13, 1404/02/23
Registration timing:prospective
Last update:2025-12-25, 1404/10/04
Update count:1
Registration date
2025-05-13, 1404/02/23
Registrant information
Name
Aliakbar Gorjipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3311 6515
Email address
aligorji3335@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-22, 1404/03/01
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Tofacitinib (Alpamont) and Adalimumab (CinnoRa) on nail lesions’ treatment in patients with Psoriatic Arthritis: A clinical trial study
Public title
Comparison of the effectiveness of tofacitinib and adalimumab in treating nail involvement in patients with psoriatic arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of psoriatic arthritis based on CASPAR criteria
Presence of nail involvement confirmed by rheumatologist and dermatologist
History of using DMARDs for controlling psoriatic arthritis
Age over 18 years
Ability to provide written informed consent
Exclusion criteria:
History of hypersensitivity to the medications used in the study
Presence of severe infections or concurrent malignancies
Pregnancy or breastfeeding
Concurrent presence of other rheumatologic diseases
History of fungal or infectious nail diseases
History of deep vein thrombosis (DVT)
History of cardiovascular diseases
Being a smoker
Use of medications that may interfere with the study drugs
Participation in other clinical trials within the past 30 days
Presence of severe psychiatric disorders affecting compliance with the study protocol
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
- Randomization Method: Randomized block design with sizes of 4, 6, and 8.
- Randomization Tool and Block Construction: The Sealed Envelope simple randomisation service website.
- Randomization Unit: Individual participants.
- No Stratification Layers: There are no stratification layers in the randomization process.
- Unique Codes: After generating the random sequence using the aforementioned online software, a unique code is assigned to each individual. The list of random sequences and unique codes is maintained by the principal investigator. Participants are enrolled in the study in the order determined by the generated random sequence.
- To ensure allocation concealment, sealed envelopes will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Highway - Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2025-05-03, 1404/02/13
Ethics committee reference number
IR.AJUMS.REC.1404.087
Health conditions studied
1
Description of health condition studied
Nail Psoriasis
ICD-10 code
L40.9
ICD-10 code description
Psoriasis, unspecified
Primary outcomes
1
Description
Nail Psoriasis Severity Index (NAPSI) score
Timepoint
At baseline (week 0) and at weeks 8, and 12 after treatment initiation.
Method of measurement
Researcher-Made Checklist
Secondary outcomes
1
Description
Incidence of treatment-related adverse events associated with tofacitinib or adalimumab in patients with psoriatic arthritis during the 12 weeks following treatment initiation.
Timepoint
Baseline (prior to initiation of treatment), Week Week 8 after treatment initiation, and Week 12 (end of treatment period).
Method of measurement
Researcher-Made Checklist
Intervention groups
1
Description
Intervention group: First Group (Tofacitinib): 5 mg oral tofacitinib tablets (brand name "Urositra," manufactured by Sobhan Darou Pharmaceutical Co., Iran) administered orally once every two weeks for a duration of 12 weeks, under treatment and evaluation.
Category
Treatment - Drugs
2
Description
Intervention Group: Group 2 (Adalimumab): 40 mg subcutaneous injection of adalimumab (brand name "Humira" by AbbVie) is administered every two weeks for a duration of 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Educational and medical Center
Full name of responsible person
Armin Jahangiri babadi
Street address
Golestan Blvd, Farvardin Street, Golestan Educational and medical Center
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3311 6515
Email
jahangiribabadi-a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdollah Rafiei
Street address
Jundishapur University of Ahvaz, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 6515
Email
rafiei-a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Aliakbar Gorjipour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan Highway
City
Khouzestan
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 6515
Fax
Email
Aligorji3335@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Aliakbar Gorjipour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan Highway
City
Khouzestan
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 6515
Fax
Email
Aligorji3335@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Aliakbar Gorjipour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Golestan Highway
City
Khouzestan
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 6515
Fax
Email
Aligorji3335@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Upon completion of the study, the following documents will be made publicly available: study protocol, statistical analysis plan, clinical study report, analysis codes, and data dictionary.
Participant data will be maintained in an anonymized format and may be shared with qualified researchers upon approval from the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences, in compliance with ethical research guidelines.
Regarding individual participant data, only information related to the primary outcome of the study will be accessible.
All data will be shared after de-identification and in adherence to ethical research principles and applicable regulations.
When the data will become available and for how long
Six Months After Publication of the Article
To whom data/document is available
Access will be granted to academic researchers and investigators actively engaged in related fields.
Under which criteria data/document could be used
Data and documents are available solely for scientific research purposes and not for commercial use. Access requires a formal request, approval from the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences, and a signed data use agreement.
From where data/document is obtainable
Researchers from the faculty, students, medical assistants, and investigators can access data by presenting an introduction letter from their respective university or institution and contacting the Research and Technology Department of Jundishapur University of Medical Sciences in Ahvaz. They must submit a proposal and obtain an ethical code from the university's ethics committee.
Applicants seeking access to the data can contact Dr. Abdollah Rafiei via email at rafiei-a@ajums.ac.ir, who serves as the Vice Chancellor for Research and Technology at Jundishapur University of Medical Sciences, and Dr. Elham Rajaei, the project manager, at rajaei-e@ajums.ac.ir.
What processes are involved for a request to access data/document
Researchers may submit requests through formal correspondence with the Research and Technology Department. Access is contingent upon obtaining ethical approval from the university's Ethics Committee.