A Rheumatoid Arthritis study in patients

Phase 3

Conditions: Rheumatoid Arthritis

Registration Number: CTRI/2012/02/002423

Lead Sponsor: Eli Lilly and Company

Brief Summary: The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in patients with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1 - unblinded treatment for up to 240 weeks for patients who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) (CTRI/2011/07/001867) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for patients who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002) (CTRI/2011/07/001870)

Period 2 - 48 week post treatment follow up

Detailed Description: Not available

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 1505

Inclusion Criteria

Completion of 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM -Woman must not be pregnant, breastfeeding, or become pregnant during the study.

Exclusion Criteria

Current symptoms of a serious disorder or illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Percentage of patients developing anti-LY2127399 antibodies	Baseline through 240 weeks
-Change from baseline in absolute B cell counts	Baseline through 240 weeks
-Change from baseline in serum immunoglobulin (Ig) levels	Baseline through 240 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response	Baseline through 240 weeks
Change from baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP)	Baseline through 240 weeks
Percentage of patients with DAS28-Based European League Against Rheumatism	Baseline through 240 weeks
Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scores	Baseline through 240 weeks
Change from baseline in Tender Joint Count (68 joint count)	Baseline through 240 weeks
Change from baseline in Swollen Joint Count (66 joint count)	Baseline through 240 weeks
Change from baseline in Patients Assessment of Pain (VAS)	Baseline through 240 weeks
Change from baseline in Patients Global Assessment of Disease Activity (VAS)	Baseline through 240 weeks
Change from baseline in Physicians Global Assessment of Disease Activity (VAS)	Baseline through 240 weeks
Change from baseline in Health Assessment Questionnaire-Disability Index HAQ-DI	Baseline through 240 weeks
Change from baseline in CRP	Baseline through 240 weeks
Mean percent improvement in ACR-N	Baseline through 240 weeks

Trial Locations

Locations (18): Apollo BGS Hospital
🇮🇳
Mysore, KARNATAKA, India
Apollo Hospital Educational and Research Foundation
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Apollo Hospitals Educational & Research Foundation
🇮🇳
Chennai, TAMIL NADU, India
BGS Global Hospital
🇮🇳
Bangalore, KARNATAKA, India
Bollineni Superspeciality Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
Global Hospitals & Health City
🇮🇳
Chennai, TAMIL NADU, India
Indraprastha Apollo Hospitals
🇮🇳
Delhi, DELHI, India
Jaipur Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Jivani Orthopedic Hospital
🇮🇳
Surat, GUJARAT, India
Krishna Institute of Medical Sciences
🇮🇳
Hyderabad, ANDHRA PRADESH, India
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Apollo BGS Hospital
🇮🇳Mysore, KARNATAKA, India
Dr Balakrishna Gowda
Principal investigator
09448054589
drtnbkg@yahoo.com