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Evolving Therapeutic Paradigms in HLA-B27 Associated Uveitis: Methotrexate, Combination Therapy, or Tofacitinib?

Treatment approach in HLA B27 associated uveitis- Comparing Methotrexate, Combination therapy and Tofacitinib - TRUST

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105145
Enrollment
60
Registered
2026-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: H209- Unspecified iridocyclitis

Interventions

Intervention1: Methotrexate, Tofacinitinib: Oral Methotrexate 25mg maximum once a week with folic acid 5mg twice a weekfor minimum 1 year Oral Tofacitinib 5mg twice a day for minimum 1 year Control I

Sponsors

Dr. Shroff Charity Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Treatment Naive HLAB27 positive Uveitis patient with recurrent Uveitis of more than 2 episodes per year with or without articular manifestation. Here Treatment naive means patients who have never been started on any immunosuppressives previously. -Treatment naive HLAB27 positive Uveitis associated with articular manifestations diagnosed using Assessment of Spondyloarthritis International Society classification criteria. -History of topical steroids use or oral steroids use of 4 weeks or less need not be excluded

Exclusion criteria

Exclusion criteria: -People who do not give consent for treatment -Patients not consenting to follow-up visits -Patients non-compliant to treatment -Current or prior treatment with any immunosuppressive agents or biologics -Major side-effects from medicines like raised liver enzymes sgot/sgpt more than 5 times, persistent low TLC count of less than 2500 or any drug intolerance -Patient unfit as deemed by the physician for receiving immunosuppressive therapy -Any active infections in the body -Pregnant female or female planning pregnancy in future.

Design outcomes

Primary

MeasureTime frame
Defined by quiescence that is absence of inflammatory activity or significant reduction in terms of AC cells, reduced Flare, AVF cells, Disc hyperaemia, CME and/or Vitritis and also no recurrence (which can be defined as absence of cells on 10th and 12th month that are last 2 follow ups)Timepoint: Monthly for 2 visits and then 2 monthly for complete 1 year. Baseline, 1 month, 2 month, 4 month, 6 month, 8 month, 10 month and 12 month.

Secondary

MeasureTime frame
Presence or Absence of Sight threatening complications like BSK, GlaucomaTimepoint: Monthly for 2 visits & then 2 monthly for complete 1 year. Baseline, 1 month, 2 month, 4 month, 6 month, 8 month, 10 month & 12 month. Number of recurrences if present Decrease in articular inflammatory activity according to ASAS criteria

Countries

India

Contacts

Public ContactTanya Jain

Dr. Shroff Charity Eye Hospital, New Delhi

tanyajain_t@yahoo.com7838333987

Outcome results

None listed

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