A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate
- Conditions
- Rheumatoid Arthritis
- Registration Number
- CTRI/2011/07/001870
- 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 treatment of rheumatoid arthritis while on a background treatment of methotrexate.
This study is comprised of three periods:
Period 1 - 52 week blinded treatment
Period 2 - additional 48 week unblinded treatment
Period 3 - 48 week post treatment follow up
H9B-MC\_BCDM(1): this addendum is to be performed in countries participating in the vaccine addendum in addition to all procedures required by the protocol H9B-MC-BCDM or any subsequent amendments to that protocol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 990
Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years -Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks -At least 8 tender and swollen joints -At least one erosion of a hand or foot joint observed on an X-ray -An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR) -Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP) antibody -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.
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 -History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD) -History of a serious reaction to other biological DMARDs -History of the use of rituximab or other B cell therapy -Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks -Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide) -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 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) at Week 24 24 weeks | Baseline, 52 weeks | Baseline, 24 weeks Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS) 24 weeks | Baseline, 52 weeks | Baseline, 24 weeks Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) 24 weeks | Baseline, 52 weeks | Baseline, 24 weeks
- Secondary Outcome Measures
Name Time Method Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response 24 weeks, 52 weeks Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scores Baseline, 24 weeks, 52 weeks Change from baseline in duration of morning stiffness (minutes) Baseline, 24 weeks, 52 weeks Percentage of patients developing anti-LY2127399 antibodies Baseline through 100 weeks Change from baseline in serum immunoglobulin (Ig) levels Baseline, 24 weeks, 52 weeks, 100 weeks Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response 24 weeks, 52 weeks Change from baseline in Disease Activity Score C-Reactive Protein (DAS28-CRP) Baseline, 24 weeks, 52 weeks Change from baseline in Brief Fatigue Inventory (BFI) individual items and impact score Baseline, 24 weeks, 52 weeks Percentage of patients with Major Clinical Response (MCR) during 52 weeks Baseline through 52 weeks Percentage of patients with change from baseline in mTSS less than or equal to 0 24 weeks, 52 weeks, 100 weeks Change from baseline in B cell subset counts Baseline, 24 weeks, 52 weeks Population Pharmacokinetics (PK) Baseline through 52 weeks Change from baseline in Brief Pain Inventory Short Form (BPI-sf) individual items and interference scores Baseline, 24 weeks, 52 weeks Percentage of patients with structural inhibition at Week 52 52 weeks Change from baseline in mTSS Baseline, 24 weeks, 100 weeks Change from baseline in joint space narrowing score and bone erosions score (components of mTSS) Baseline, 24 weeks, 52 weeks, 100 weeks Mean percent improvement in ACR N 24 weeks, 52 weeks Change from baseline in Tender Joint Count (68 joint count) Baseline, 24 weeks, 52 weeks Change from baseline in Patients Assessment of Pain (VAS) Baseline, 24 weeks, 52 weeks Change from baseline in Swollen Joint Count (66 joint count) Baseline, 24 weeks, 52 weeks Percentage of patients with ACR20 at Week 52 52 weeks Change from baseline in Patients Global Assessment of Disease Activity (VAS) Baseline, 24 weeks, 52 weeks Change from baseline in Physicians Global Assessment of Disease Activity (VAS) Baseline, 24 weeks, 52 weeks Change from baseline to Week 52 in HAQ-DI Baseline, 52 weeks Change from baseline in absolute B cell counts Baseline, 24 weeks, 52 weeks, 100 weeks Time to ACR20 response Baseline through 24 and 52 weeks Change from baseline in CRP Baseline, 24 weeks, 52 weeks
Trial Locations
- Locations (19)
Apollo BGS Hospital
🇮🇳Mysore, KARNATAKA, India
Apollo Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Apollo Hospitals Chennai
🇮🇳Chennai, TAMIL NADU, India
BGS Global Hospital
🇮🇳Bangalore, KARNATAKA, India
Bollineni Superspeciality Hospital
🇮🇳Nellore, ANDHRA PRADESH, India
Global Hospitals
🇮🇳Chennai, TAMIL NADU, 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 (9 remaining)Apollo BGS Hospital🇮🇳Mysore, KARNATAKA, IndiaBalakrishna GowdaPrincipal investigator9182125666665drtnbkg@yahoo.com