Comparing the effectiveness of Tofacitinib (Alpamont) and Adalimumab (CinnoRa) on nail lesions’ treatment in patients with Psoriatic Arthritis: A clinical trial study

To evaluate the efficacy and safety of tofacitinib versus adalimumab in treating nail, joint, and skin involvement in psoriatic arthritis patients.

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).

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.

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.

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.

Primary outcomes: Changes in Nail Psoriasis Severity Index (NAPSI) and Lesion Quadrant Index from baseline to week 12.

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.

- 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.

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.

Six Months After Publication of the Article

Access will be granted to academic researchers and investigators actively engaged in related fields.

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.

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.

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.