Health Condition 1: null- Active Rheumatoid arthritis Health Condition 2: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
Conditions
Interventions
Intervention1: secukinumab (AIN457)75 mg: secukinumab (AIN457)75 mg plus placebo 150 mg subcutaneously once weekly at Baseline, Weeks 1, 2, 3
and 4, followed by dosing every four weeks starting at Wee
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed 2. Male or non-pregnant, non-lactating female subjects at least 18 years of age 3. Presence of RA classified by ACR 2010 revised criteria (see Appendix 2) 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-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 4. Subjects must have been taking at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab 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
Exclusion criteria
Exclusion criteria: 1. Chest x-ray or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician 2. RA subjects functional status class IV according to the ACR 1991 revised criteria (see Appendix 3) 3. Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) 4. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor 5. Use of any investigational drug and/or devices within 4 weeks before randomization, or a period of 5 half-lives of the investigational drug, whichever is longer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo in patients with active RA based on the proportion of patients achieving an ACR20 response.Timepoint: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo in patients with active RA based on the proportion of subjects achieving an ACR50 responseTimepoint: upto 52 weeks;To demonstrate the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo with respect to the improvement (change) from baseline in HAQ-DITimepoint: upto 52 weeks | — |
Countries
Argentina, Brazil, Colombia, Czech Republic, Dominican Republic, Ecuador, Germany, Greece, Guatemala, India, Italy, Panama, Portugal, Republic of Korea, South Africa, United States of America
Contacts
Public ContactMurugananthan K
Novartis Healthcare Private Limited,
Outcome results
None listed