NCT03736161: PsOLSET-BD

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

Completed Phase 3 Last updated 21 October 2019

What this trial tests

Phase 3 trial testing Group A- Tofacitinib in Psoriatic Arthritis in 61 participants. Completed in 28 September 2019.

Timeline

15 September 2017

Primary endpoint
28 September 2019

28 September 2019

Quick facts

Lead sponsor	Globe Pharmaceuticals Limited
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	15 September 2017
Primary completion	28 September 2019
Estimated completion	28 September 2019
Sites	1 location across Bangladesh

Drugs / interventions tested

• Group A- Tofacitinib — full drug profile →
• Group B- Methotrexate — full drug profile →

Conditions studied

• Psoriatic Arthritis — all drugs for Psoriatic Arthritis →

Sponsor

Globe Pharmaceuticals Limited — full company profile →

Who can join

18 and older, any sex, with Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emerging Topical and Systemic JAK Inhibitors in Dermatology.
   Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
2. JAK/STAT pathway: Extracellular signals, diseases, immunity, and therapeutic regimens.
   Hu Q, Bian Q, Rong D, Wang L, et al · · 2023 · cited 190× · PMID 36911202 · DOI 10.3389/fbioe.2023.1110765
3. Immune cells in the epithelial immune microenvironment of psoriasis: emerging therapeutic targets.
   Li L, Lu J, Liu J, Wu J, et al · · 2023 · cited 26× · PMID 38239345 · DOI 10.3389/fimmu.2023.1340677