To assess long term efficacy, safety, tolerability and usability of Secukinumab in patients with active Rheumatid Artheritis

Phase 3

• Conditions: Rheumatoid arthritis with rheumatoid factor, unspecified,

• Registration Number: CTRI/2014/04/004518
• Lead Sponsor: Novartis Healthcare Pvt Ltd

Brief Summary

**A phase 3 trial to demonstrate  the efficacy at 24 weeks and to assess the long term efficacy, safety, tolerability and usability up to 5 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents.**

**Planned no. of patients from India: 25**

**FPFV achived on 27 Feb 2014 from India**

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-27
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 242

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

• 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.
• 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	52 weeks
response.	52 weeks
placebo in patients with active RA based on the proportion of patients achieving an ACR20	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	to placebo in patients with active RA based on the proportion of subjects achieving an
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-DI

Trial Locations

Locations (6)

Inamdar Multispecialty Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Krishna Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Malpani Multispeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Medipoint Hospitals Pvt. Ltd; 🇮🇳 Pune, MAHARASHTRA, India

Sir Ganga Ram Hospital; 🇮🇳 Delhi, DELHI, India

Sumana Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Inamdar Multispecialty Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Ajit Nalawade

Principal investigator

020-41236660

dr.ajitnalawade@gmail.com