Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
- Conditions
- Rheumatoid Arthritis
- Registration Number
- CTRI/2011/12/002247
- Lead Sponsor
- Novartis Healthcare Pvt Ltd
- Brief Summary
Purpose of study:
This study will assess the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis (RA) who are intolerant to or have had an inadequate response to anti-tumor necrosis factor (TNF)-α agents.
FPFV:29-Dec -2011
Enrolment target for India:50
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 630
Male or non-pregnant, non-lactating female patients Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening At Baseline: Disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6 swollen joints out of 66 with at least 1 of the following at screening: Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following at screening: High sensitivity C-reactive protein (hsCRP) ≥ 10 mg/L OR Erythrocyte sedimentation rate (ESR) ≥ 28 mm/1st hr Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan only: 6 to 25 mg/week).
Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria Patients who have ever received biologic immunomodulating agents except for those targeting TNFα Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19) Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX) Time Frame:24 weeks
- Secondary Outcome Measures
Name Time Method 1.improvement (change) of the Health Assessment Questionnaire - Disability Index (HAQ-DI) from baseline on secukinumab 75 mg or 150 mg compared to placebo 2.change of the van der Heijde total modified Sharp score on secukinumab 75 mg or 150 mg or both secukinumab doses is superior to placebo
Trial Locations
- Locations (14)
Asha Health Pit
🇮🇳Bangalore, KARNATAKA, India
Chanre Rheumatology & Immunology Centre & Research (CRIC&R)
🇮🇳Bangalore, KARNATAKA, India
Jivani Orthopedic, Arthosccopy and Joint Replacement Center
🇮🇳Surat, GUJARAT, India
Kokilaben Dhirubhai Ambani Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Krishna Institute of Medical Sciences
🇮🇳Hyderabad, ANDHRA PRADESH, India
Malpani Multispeciality Hospital
🇮🇳Jaipur, RAJASTHAN, India
Mavens Hospitals
🇮🇳Ajmer, RAJASTHAN, India
Pace Clinical Research Centre
🇮🇳Bangalore, KARNATAKA, India
Pentagon Research Pvt. Ltd
🇮🇳Pune, MAHARASHTRA, India
Shalby Hospital
🇮🇳Ahmadabad, GUJARAT, India
Scroll for more (4 remaining)Asha Health Pit🇮🇳Bangalore, KARNATAKA, IndiaDrDineshSPrincipal investigator919886125229bhaktha.dinesh@gmail.com