Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis

• Status: Completed
• Trial end date: 2019-09-28
• Target enrollment: 0
• Participant gender: All

Summary

Title Safety and Efficacy of Tofacitinib vs Methotrexate in the treatment of Psoriatic Arthritis- An Open Label Randomized single center study Psoriatic arthritis is defined as an inflammatory arthropathy associated with skin psoriasis and usually negative for rheumatoid factor. Till date, many NSAIDs, corticosteroids, DMARDs have been used, but the safety and efficacy issues demands more researches. The prevalence of PsA worldwide is about 1%-2% and among patients with psoriasis ranges from 7% to 42%. The pathogenesis of PsA involves many cytokines. Tofacitinib is an oral Janus Kinase (JAK) inhibitor with immunomodulatory and anti-inflammatory mechanism. It binds to JAK and prevents the activation of the JAK-signal transducers and activators of transcription (STAT) signaling pathway which ultimately decreases the production of pro-inflammatory cytokines, and prevents both inflammatory response and the inflammation-induced damage. It has shown better efficacy in many diseases like Rheumatoid Arthritis, Axial spondyloarthropathies, Psoriasis, Psoriatic Arthritis, Alopecia areata, dry eye disease.

This prospective, open label, randomized study will be conducted in inpatient and outpatient departments of Rheumatology, BSMMU, Dhaka, Bangladesh in 110 adult volunteers (>18 years) of both genders diagnosed as psoriatic arthritis. Patients will be divided equally into two groups, Group A will be put on Tofacitinib 5 mg twice daily and Group B will be put on Methotrexate weekly in increasing dose with maximum dose of 25 mg weekly. Groups will be divided on the basis of randomization by random number table. Patients with inadequate response to highest dose of MTX or Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 5 mg BD or Tofacitinib 10 mg BD respectively. The patients not eligible for therapy will not be included in the study. Patients will be followed up at 1, 3 and 6 months. Baseline characteristics will be monitored and recorded at 3 and 6 months.

The clinical information of the study subjects will be recorded in a structured history, clinical examination and questionnaire. All subjects will be enrolled after having informed written consent. The participants will enjoy every right to participate or withdraw from the study at any point of time. Response to Tofacitinib will be expressed in mean, standard deviation and percentage. Ethical clearance will be taken from the Institutional Review Board (IRB) of BSMMU.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Globe Pharmaceuticals Limited
• Collaborator: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Methotrexate; Tofacitinib

Criteria

Inclusion Criteria:

1. Male or female patients more than 18 years

2. Psoriatic arthritis > 3 months with peripheral involvement diagnosed on the basis of CASPAR criteria

3. Unresponsive to more than 2 NSAIDs at maximum recommended doses for more than 4 weeks, i.e 2 weeks for each NASID

5. Patients with active disease 6. PsA with or without extra-articular features like enthesitis, dactylitis and nail changes

Exclusion Criteria:

1. Systemic infections requiring hospital admission during the past 6 months

2. A history of active infectious disorders (including active or latent tuberculosis), and/or a history of chronic or recurrent serious infective diseases, opportunistic infections

3. Hemoglobin (Hb) < 9 g/dl

4. White blood cell count < 3000, Neutrophil count < 1000, Platelet count < 100000

5. Live vaccines within 3 months prior to the first dose

6. Serum creatinine > upper limit of normal reference range

7. GFR less than 50 mL/min

8. Alanine aminotransaminase (ALT) more than 2 times of ULN

9. Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception

10. New York Heart Association Class III and IV congestive heart failure

11. Evidence or history of malignancy, with the exception of adequately treated or excised non-metastatic basal or squamous cell cancer of the skin or cervical carcinoma in situ

12. Any lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease