Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents.
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | September 2011 |
End Date: | February 2015 |
A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents
This study will assess the safety and efficacy of secukinumab when added to a background
therapy in patients with active rheumatoid arthritis who are intolerant to or have had an
inadequate response to anti-TNF-α agents.
therapy in patients with active rheumatoid arthritis who are intolerant to or have had an
inadequate response to anti-TNF-α agents.
Inclusion Criteria:
- Male or non-pregnant, non-lactating female patients
- Presence of RA classified by ACR 2010 revised criteria for at least 3 months before
screening
- At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >=
6 swollen joints out of 66
WITH at least 1 of the following at screening:
- Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR
- Rheumatoid Factor positive
AND WITH at least 1 of the following at screening:
- High sensitivity C-Reactive Protein (hsCRP) >= 10 mg/L OR
- Erythrocyte Sedimentation Rate (ESR) >= 28 millimeter (mm)/1st hour
- Patients must have been taking at least one anti-TNF-α 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-α agent
- Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at
least 3 months before randomization and have to be on a stable dose at least 4 weeks
before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated
dose)
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 TNFα
- Previous treatment with any cell-depleting therapies
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
48
sites
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