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A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents

A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNF-alpha agents

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221561
Enrollment
Unknown
Registered
2011-09-05
Start date
2011-09-05
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Rheumatoid Arthritis

Interventions

investigational material(s) Generic name etc : Secukinumab INN of investigational material : Secukinumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration f

Sponsors

Novartis Pharma K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening -Patients must have been taking at least one anti-TNF-alpha agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-alpha agent

Exclusion criteria

Exclusion criteria: -Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria -Patients who have ever received biologic immunomodulating agents except for those targeting TNF-alpha - Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

MeasureTime frame
efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX) [ Time Frame: Week 24 ]—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026