CTRI/2011/07/001870招募中3 期
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 990
- 试验地点
- 19
- 主要终点
- Percentage of patients with American College of Rheumatology 20% response (ACR20) at Week 24
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of patients with American College of Rheumatology 20% response (ACR20) at Week 24
时间窗: 24 weeks | Baseline, 52 weeks | Baseline, 24 weeks
Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS)
时间窗: 24 weeks | Baseline, 52 weeks | Baseline, 24 weeks
Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)
时间窗: 24 weeks | Baseline, 52 weeks | Baseline, 24 weeks
次要结局
- 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 Patients Global Assessment of Disease Activity (VAS)(Baseline, 24 weeks, 52 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 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)
研究者
研究点 (19)
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