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 arthritis; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-024516-34-SK
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-13
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 215

Inclusion Criteria

- 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

Exclusion Criteria

- 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