A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
| 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: | February 2014 |
A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension
This study aims to confirm if patients with a specific biomarker might have a better
response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will
be done. The goals of these exploratory studies are to (1) find biomarkers that will
identify persons with rheumatoid arthritis who will have the best possible response to
secukinumab and (2) to identify persons who will have fewer side effects in order to
maximize their benefit from secukinumab.
response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will
be done. The goals of these exploratory studies are to (1) find biomarkers that will
identify persons with rheumatoid arthritis who will have the best possible response to
secukinumab and (2) to identify persons who will have fewer side effects in order to
maximize their benefit from secukinumab.
Inclusion Criteria:
- Diagnosis of rheumatoid arthritis
- Patients must be either DMARD naive or have failed at least one DMARD agent (e.g.
MTX, leflunamide or sulfasalazine)
- Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or
hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating
study treatment
- Disease activity at screening defined by ≥6 out of 28 tender joints and ≥6 out of 28
swollen joints and hsCRP >10mg/L
Exclusion Criteria:
- Patients with severe rheumatoid arthritis (functional status class IV according to
the ACR 1991 revised criteria)
- Previous exposure to secukinumab or any other biologic, including TNF inhibitors.
- Use of high potency opioid analgesics
- Pregnant or nursing (lactating) women
- Use of any investigational drug other than RA therapy and/or devices at the time of
randomization or within 30 days or 5 half-lives of randomization, whichever is
longer.
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
17
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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