]>
IRCT20260715070199N1 IRCT 2026-08-12 Tehran University of Medical Sciences Effect of Azithromycin in treatment of Rheumatoid Arthritis Investigation of the effect of azithromycin on disease activity in rheumatoid arthritis patients 2026-08-23 anticipated 74 Recruiting https://irct.ir/trial/91736 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The unit of randomization in this study is the individual. Patients are assigned to the intervention and control groups using simple randomization with a 1:1 allocation ratio. The random allocation sequence is generated using computer-generated random numbers. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes are utilized. An independent researcher, who is not involved in patient enrollment or assessment, generates the sequence and prepares the envelopes. Consequently, the group allocation for each patient remains strictly concealed until the respective envelope is opened at the time of intervention, Blinding description: This study is designed as a randomized, double-blind, placebo-controlled trial. To prevent bias and ensure the integrity of the study, the following groups will be blinded to the treatment allocation: Trial Participants: Patients will be completely unaware of their assigned group. Both the active medication (Azithromycin 500 mg) and the placebo (a cornstarch-based formulation manufactured by Exir Pharmaceutical Company) are visually identical in shape, size, and color. The medications will be provided to participants in sealed, opaque, and identically coded envelopes without any identifying labels. Principal Investigator and Healthcare Providers: The treating physicians and healthcare staff responsible for enrolling patients, providing routine care, and dispensing the study packages will be blinded to the allocation sequence. They will only have access to the predefined random codes on the envelopes. Data Collectors and Outcome Assessors: The researchers responsible for clinical evaluations, calculating disease activity scores, and recording patient data will remain blinded to the treatment assignment to ensure unbiased clinical assessments. Mechanism of Blinding: An independent third-party researcher, who has no role in patient recruitment, clinical care, or outcome assessment, will be exclusively responsible for generating the allocation sequence, preparing the identical drug/placebo packages, and labeling them with random codes. This independent individual will keep the master blinding code secure and confidential until the data collection phase is fully completed and the database is locked for analysis. 3 Rheumatoid Arthritis. Intervention 1: Intervention group: Patients in this group, in addition to their standard Rheumatoid Arthritis treatment, will receive oral Azithromycin 500 mg tablets (manufactured by Exir Pharmaceutical Company) three times a week (one tablet on Saturdays, Sundays, and Mondays) for 12 weeks. Intervention 2: Control group: In addition to receiving standard treatment for Rheumatoid Arthritis (RA) based on guidelines, patients in this group receive a placebo. The placebo is administered as an oral tablet based on cornstarch, completely identical in appearance to the active medication, given three times a week (one tablet on Saturdays, Sundays, and Mondays) for a duration of 12 weeks. The placebo is manufactured by Exir Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: Deidentified Individual Participant Data (IPD) for all primary and secondary outcome measures will be shared. When: Data will become available 6 months after the publication of the results and will remain accessible for a period of 2 years. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Data can be used exclusively for non-commercial academic research, systematic reviews, and meta-analyses. Requests must include a formal, methodologically sound proposal approved by an independent ethics committee. Where to obtain: Applicants should send their requests via email to the principal investigator (Soheil Khalaji) at soheil.gpi@gmail.com. How to obtain: Applicants must submit a formal request along with their research proposal and ethics committee approval via email. The principal investigator and the research team will review the request within 4 weeks. If approved, a data-sharing agreement must be signed before the deidentified data is transferred securely. The entire process is estimated to take up to 2 months. Comments:
public Soheil Khalaji
Rheumatology Department, Imam Khomeini Hospital Complex, Gharib St, Keshavarz Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6691 1294 soheil.gpi@gmail.com Tehran University of Medical Sciences scientific Soheil Khalaji
Rheumatology Department, Imam Khomeini Hospital Complex, Gharib St, Keshavarz Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1461884513 +98 21 6691 1294 soheil.gpi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Confirmed diagnosis of Rheumatoid Arthritis (RA) based on the ACR-2020 criteria Receiving standard treatment for RA Having active disease at the time of enrollment 18 years no limit Both Current use of biologic agents for the treatment of RA Concurrent use of antibiotics Any contraindications to the administration of macrolides Having inactive disease at the time of study entry Need to change treatment to biologic agents at the initial visit M06.9 Rheumatoid arthritis, unspecified Treatment - Drugs Placebo Intervention group: Patients in this group, in addition to their standard Rheumatoid Arthritis treatment, will receive oral Azithromycin 500 mg tablets (manufactured by Exir Pharmaceutical Company) three times a week (one tablet on Saturdays, Sundays, and Mondays) for 12 weeks. Control group: In addition to receiving standard treatment for Rheumatoid Arthritis (RA) based on guidelines, patients in this group receive a placebo. The placebo is administered as an oral tablet based on cornstarch, completely identical in appearance to the active medication, given three times a week (one tablet on Saturdays, Sundays, and Mondays) for a duration of 12 weeks. The placebo is manufactured by Exir Pharmaceutical Company. Disease Activity Score 28 based on Erythrocyte Sedimentation Rate. Timepoint: At the beginning of the study (before intervention) and twelve weeks after the start of the intervention. Method of measurement: Calculated via standard formula using the number of swollen and tender joints in clinical examination, patient global assessment of disease activity, and laboratory value of Erythrocyte Sedimentation Rate. Disease Activity Score 28 based on C Reactive Protein. Timepoint: At the beginning of the study (before intervention) and twelve weeks after the start of the intervention. Method of measurement: Calculated via standard formula using the number of swollen and tender joints in clinical examination, patient global assessment of disease activity, and laboratory value of C Reactive Protein. Clinical Disease Activity Index. Timepoint: At the beginning of the study (before intervention) and twelve weeks after the start of the intervention. Method of measurement: Calculated as the sum of the number of swollen joints, number of tender joints, patient global assessment, and evaluator global assessment. Simplified Disease Activity Index. Timepoint: At the beginning of the study (before intervention) and twelve weeks after the start of the intervention. Method of measurement: Calculated as the sum of the number of swollen joints, number of tender joints, patient global assessment, evaluator global assessment, and laboratory value of C Reactive Protein. Tehran University of Medical Sciences Approved 2024-08-06 Ethics committee of Tehran University of Medical Sciences School of Medicine, Poursina St., Qods St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)