Status:
COMPLETED
A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01426789
Start Date
August 1 2011
End Date
February 1 2014
Last Update
August 10 2015
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Phoenix, Arizona, United States, 85023
2
Novartis Investigative Site
Tuscon, Arizona, United States, 85724
3
Novartis Investigative Site
Anahiem, California, United States, 92804
4
Novartis Investigative Site
Clearwater, Florida, United States, 33756