Safety and Efficacy of Tofacitinib vs Methotrexate in the Treatment of Psoriatic Arthritis
Status:
Completed
Trial end date:
2019-09-28
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Globe Pharmaceuticals Limited
Collaborator:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh