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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250503065587N1
Enrollment
70
Registered
2025-05-13
Start date
2025-05-22
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nail Psoriasis. Psoriasis, unspecified

Interventions

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 eve

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAliakbar Gorjipour

Ahvaz University of Medical Sciences

Aligorji3335@gmail.com+98 61 3311 6515

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026