A study identifying blood serum markers that predict response to a 12 week treatment with secukinumab in patients with Rheumatoid Arthritis
- Conditions
- Rheumatoid ArthritisMedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-001220-38-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
- 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
Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 375
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125
- 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 rheumatoid arthritis 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 exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess if the treatment effect of Secukinumab in patients with Rheumatoid Arthritis after 12 weeks treatment is associated with a certain genetic disposition;Secondary Objective: To assess if the treatment effect of Secukinumab in patients with Rheumatoid Arthritis is associated with any other blood markers and to further assess the safety and tolerability of this drug;Primary end point(s): Evaluation of clinical response according to validated methods DAS (disease activity index) and ACR (American College of Rheumatology), with regards to a 20% improvement compared to baseline;Timepoint(s) of evaluation of this end point: 12 weeks assessment of ACR and DAS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Evaluation of clinical response according to a validated methods DAS (disease activity index) and ACR (American College of Rheumatology), with regards to a 50% resp. 70% improvement compared to baseline.<br>Assessing the safety and tolerability of secukinumab;Timepoint(s) of evaluation of this end point: Assessment performed at each dosing visit with main focus of 12 weeks timepoint and end of study