A Rheumatoid Arthritis Study in Patients

Phase 3

Recruiting

Conditions: Rheumatoid Arthritis

Registration Number: CTRI/2011/07/001867

Lead Sponsor: Eli Lilly and Company

Brief Summary: The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatmetn of rheumatoid arthritis while with or without background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.

This study is comprised of 2 periods:

Period 1 - 24 week blinded treatment

Period 2 - 48 week post treatment follow up

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 1002

Inclusion Criteria

Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years -Global Assessment of Disease Activity visual analog scale (VAS)greater than or equal to 20/100 mm -If on one or more conventional DMARDs at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
Woman must not be pregnant, breastfeeding, or become pregnant during the study -Age limit in India per Office of Drug Controller General India is 18 years to 65 years.

Exclusion Criteria

Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks -Steroid injection or intravenous (iv) infusion in the last 6 weeks -Use of more than 10 mg/day of oral steroids in the last 6 weeks -Use of biologic DMARD concurrently or recently -History of a serious reaction to other biological DMARDs -Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks -Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study -Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA -Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years -Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines) -Hepatitis or human immunodeficiency virus (HIV) -A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months -Symptoms of herpes zoster or herpes simplex within the last month -Active or latent tuberculosis (TB) Current symptoms of a serious disorder or illness -Use of an investigational drug within the last month.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with American College of Rheumatology 20% response (ACR20)	24 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response	24 weeks
Mean percent improvement in ACR-N	24 weeks
Change from baseline to 24 weeks in Tender Joint Count (68 joint count)	baseline, 24 weeks
Change from baseline to 24 weeks in Swollen Joint Count (66 joint count)	baseline, 24 weeks
Change from baseline to 24 weeks in Patients Assessment of Pain (VAS)	baseline, 24 weeks
Change from baseline to 24 weeks in Patients Global Assessment of Disease Activity (VAS)	baseline, 24 weeks
Change from baseline to 24 weeks in Physicians Global Assessment of Disease Activity (VAS)	baseline, 24 weeks
Change from baseline to 24 weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)	baseline, 24 weeks
Change from baseline to 24 weeks in Disease Activity Score-C-Reactive Protein (DAS28-CRP)	baseline, 24 weeks
Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response	24 weeks
Change from baseline to 24 weeks in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain and summary scores	baseline, 24 weeks
Time to ACR20 response	baseline through 24 weeks
Change from baseline to 24 weeks in absolute B cell counts	baseline, 24 weeks
Change from baseline to 24 weeks in serum immunoglobulin (Ig) levels	baseline, 24 weeks
Population Pharmacokinetics (PK)	baseline through 24 weeks
Percentage of patients developing anti-LY2127399 antibodies	baseline through 24 Weeks
Change from baseline to 24 weeks in CRP	baseline, 24 weeks

Trial Locations

Locations (20): Apollo BGS Hospital
🇮🇳
Mysore, KARNATAKA, India
Apollo Hospital
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Apollo Hospital Chennai
🇮🇳
Chennai, TAMIL NADU, India
BGS Global Hospital
🇮🇳
Bangalore, KARNATAKA, India
Bollineni Superspeciality Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
Global Hospitals
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Indraprastha Apollo Hospital
🇮🇳
Delhi, DELHI, India
Jaipur Hospital
🇮🇳
Jaipur, RAJASTHAN, India
Jivani Orthopedic Hospital
🇮🇳
Surat, GUJARAT, India
King George Hospital, Andhra Medical College
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Scroll for more (10 remaining)
Apollo BGS Hospital
🇮🇳Mysore, KARNATAKA, India
Balakrishna Gowda
Principal investigator
918212566666
drtngkg@yahoo.com