To assess long term efficacy, safety, tolerability and usability of Secukinumab in patients with active Rheumatid Artheritis
- Conditions
- Health Condition 1: null- Active Rheumatoid arthritisHealth Condition 2: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
- Registration Number
- CTRI/2014/04/004518
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- Not specified
- Target Recruitment
- 20
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to <br/ ><br>placebo in patients with active RA based on the proportion of patients achieving an ACR20 <br/ ><br>response.Timepoint: 52 weeks
- Secondary Outcome Measures
Name Time Method To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior <br/ ><br>to placebo in patients with active RA based on the proportion of subjects achieving an <br/ ><br>ACR50 responseTimepoint: upto 52 weeks;To demonstrate the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to <br/ ><br>placebo with respect to the improvement (change) from baseline in HAQ-DITimepoint: upto 52 weeks