Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | August 2011 |
End Date: | September 2015 |
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-TNFα Agents.
This study will assess the safety and efficacy of secukinumab when added to a background
therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had
an inadequate response to anti-tumor necrosis factor (TNF)-α agents.
therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had
an inadequate response to anti-tumor necrosis factor (TNF)-α agents.
Inclusion criteria:
- Male or non-pregnant, non-lactating female patients
- Presence of RA classified by American College of Rheumatology (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 (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 mm/1st hr
- 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 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 Japan
only: 6 to 25 mg/week)
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 including but not limited to
anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
anti-CD19)
- Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
43
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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