Compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis despite treatment with methotrexate
- Conditions
- Rheumatoid arthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-024516-34-BG
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 215
- Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months before screening
- Must have been taking Methotrexate for at least 3 months before randomization and must currently be on a stable dose of Methotrexate for at least 4 weeks before randomization
- At baseline : disease activity criteria defined by = 6 tender joints out of 68 and = 6 swollen joints out of 66 and with at least 1 of the following at screening: anti-CCP antibodies positive or rheumatoid factor positive and with at least 1 of the following at screening: hsCRP = 10 mg/L or ESR = 28 mm/1st hr
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 172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 43
- Rheumatoid arthritis patients functional status class IV according to the ACR 1991 revised criteria
- Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
- Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic agent (experimental or approved)
- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
- Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization.
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 demonstrate the superior efficacy of secukinumab administered during induction with an i.v. loading regimen or a s.c. loading dose regimen compared to placebo in patients with active rheumatoid arthritis despite treatment with methotrexate using the ACR 20 criteria.;Secondary Objective: To compare the secukinumab regimens (i.v. and s.c.) to placebo and to each other for ACR 20, ACR 50 and ACR 70 response criteria, Health Assessment Questionnaire-Disability Index, Disease Activity Score (DAS) 28 response, ACR components, including markers of inflammation and to evaluate the overall safety and tolerability of secukinumab and investigate the development of immunogenicity against secukinumab.;Primary end point(s): Response to treatment according to ACR 20 criteria;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - ACR 20, ACR 50, and ACR 70 response criteria<br>- Change from baseline in HAQ-DI values<br>- DAS28-CRP, DAS28-ESR, and EULAR response criteria <br>- ACR component variables;Timepoint(s) of evaluation of this end point: For all secondary endpoints: every visit, Week 0 to 52<br>