A CLINICAL TRIAL TO STUDY THE EFFECT OF TWO DRUGS JAK INHIBITORS (TOFACITINIB) AND NSAIDS ON PATIENTS WITH AXIAL SPONDYLOARTHROPATHIES

A COMPARATIVE STUDY BETWEEN OUTCOME OF JAK INHIBITORS (TOFACITINIB) AND NSAIDS ON PATIENTS WITH AXIAL SPONDYLOARTHROPATHIES - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066083

Enrollment

100

Registered

2024-04-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: M450- Ankylosing spondylitis of multiplesites in spine

Interventions

Intervention1: Tofacitinib 5 mg: Tofacitinib 5 mg twice daily after food for four weeks Control Intervention1: Aceclofenac 100mg: Aceclofenac 100mg twice daily after food for four weeks

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosed Cases of Ankylosing Spondylitis, 2. Patients with no Medical Contraindication, 3. Skeletally Mature Patients.

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years, 2. Patients with active infections (tb & other viral and bacterial infection), 3. Pregnant, Lactating women.

Design outcomes

Primary

Measure	Time frame
To compare the clinical improvement between the two groups.Timepoint: To compare the clinical improvement between the two groups at 4 weeks, 8 weeks, 12 weeks.	—

Secondary

Measure	Time frame
1. To compare the efficacy of the drugs between two groups. 2. To compare the incidence of side effects of the drugs between the two groups. 3. To compare the ASAS 20/ ASAS 40 response between the two groups. 4. To compare the improvement of ASDAS/BASDAI score between two groups.Timepoint: 1. 4, 8, 12 weeks 2. 4, 8, 12 weeks 3. 4, 8, 12 weeks 4. 4, 8, 12 weeks	—

Countries

India

Contacts

Public ContactDr. Nilotpal Saikia

Gauhati Medical College and Hospital

herman32541@gmail.com9435032541

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026