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IRCT20250503065587N1 IRCT 2025-05-13 Ahvaz University of Medical Sciences Comparison of the effectiveness of tofacitinib and adalimumab in treating nail involvement in patients with psoriatic arthritis Comparing the effectiveness of Tofacitinib (Alpamont) and Adalimumab (CinnoRa) on nail lesions’ treatment in patients with Psoriatic Arthritis: A clinical trial study 2025-05-22 anticipated 70 Complete https://irct.ir/trial/83319 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 Nail Psoriasis. Intervention 1: 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 2: 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. Yes - There is a plan to make this available What will be shared: 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: Six Months After Publication of the Article To whom: Access will be granted to academic researchers and investigators actively engaged in related fields. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Aliakbar Gorjipour
Golestan Highway
Khouzestan Iran (Islamic Republic of) 6135715794 +98 61 3311 6515 Aligorji3335@gmail.com Ahvaz University of Medical Sciences scientific Aliakbar Gorjipour
Golestan Highway
Khouzestan Iran (Islamic Republic of) 6135715794 +98 61 3311 6515 Aligorji3335@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 L40.9 Psoriasis, unspecified Treatment - Drugs Treatment - Drugs 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: 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. 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. 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. Ahvaz University of Medical Sciences Approved 2025-05-03 Biomedical Research Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)