A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

NCT01198002 | Terminated Phase 3 Results DMC

• 3 other identifiers: 11352H9B-MC-BCDMCTRI/2011/07/001870
• Study Type: interventional
• Target: 1,041
• Locations: 23 countries
• Sites: 234

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 3 periods: Period 1: 52-week blinded treatment Period 2: additional 48-week unblinded treatment Period 3: 48-week post-treatment follow-up

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24

  ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responder: had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders) / (number of participants treated) \* 100. All NR at Week 16 as well as all participants who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Week 24 endpoint.

  Baseline through 24 weeks

• Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS)

  The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints. X-rays of the hands/wrists and feet are scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosions scores (range = 0 to 220 for 44 joints) and narrowing scores (range = 0 to 168 for 42 joints) were added to obtain the mTSS (range = 0 \[normal\] to 388 \[maximal disease\]). Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate.

  Baseline, 52 Weeks

• Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)

  The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty \[0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)\] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  Baseline, 24 weeks

Secondary Outcomes (27)

• Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response

  Baseline through 24 weeks and 52 weeks

• Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP)

  Baseline, 24 weeks and 52 weeks

• Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response

  Baseline through 24 weeks and 52 weeks

• Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores

  Baseline, 24 weeks and 52 weeks

• Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score

  Baseline, 24 weeks and 52 weeks

Other Outcomes (1)

• Number of Participants Who Died During Post-Treatment Follow-Up Period

  Discontinuation from study treatment up to 48 weeks during follow-up period

Study Arms (3)

120 milligrams (mg) LY2127399

EXPERIMENTAL

Given every 4 weeks (Q4W) for 100 weeks. Participants receive a 240 mg loading dose when initiating treatment. During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W). At Weeks 16 and 52, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

Drug: LY2127399; Drug: Placebo Q4W; Drug: Methotrexate

90 mg LY2127399

EXPERIMENTAL

Given Q2W for 100 weeks. Participants receive a 180 mg loading dose when initiating treatment. At Weeks 16 and 52, responders will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q4W for the rest of the 100-week treatment period. At Week 16, NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

Drug: LY2127399; Drug: Methotrexate

Placebo

PLACEBO COMPARATOR

Given Q2W for 52 weeks. At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 52 weeks. At Week 52, responders are randomized to receive 1 of the 2 doses of LY2127399, with loading dose of 240 mg or 180 mg of LY2127399, followed by 120 mg of LY2127399 Q4W or 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period. At Week 16, NR will receive a loading dose of 180 mg of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 100-week treatment period.

Drug: LY2127399; Drug: Placebo Q2W; Drug: Methotrexate

Interventions

LY2127399 DRUG

Administered Subcutaneously (SC)

120 milligrams (mg) LY2127399; 90 mg LY2127399; Placebo

Placebo Q2W DRUG

Administered SC

Placebo

Placebo Q4W DRUG

Administered SC

120 milligrams (mg) LY2127399

Methotrexate DRUG

Methotrexate is a background therapy.

120 milligrams (mg) LY2127399; 90 mg LY2127399; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6 weeks
• Steroid injection or intravenous (iv) infusion in the last 6 weeks
• Use of more than 10 milligrams/day (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, Crohn's 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (234)

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Birmingham, Alabama, 35216, United States

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Huntsville, Alabama, 35801, United States

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Paradise Valley, Arizona, 85253, United States

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85018, United States

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Scottsdale, Arizona, 85251, United States

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Hot Springs, Arkansas, 71913, United States

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Little Rock, Arkansas, 72205, United States

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Escondido, California, 92027, United States

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Fresno, California, 93720, United States

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Hemet, California, 92543, United States

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La Jolla, California, 92037, United States

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La Mesa, California, 91942, United States

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Sacramento, California, 95825, United States

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Torrance, California, 90505, United States

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Tustin, California, 92780, United States

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Upland, California, 91786, United States

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Wildomar, California, 92595, United States

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Colorado Springs, Colorado, 80910, United States

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Denver, Colorado, 80209, United States

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Danbury, Connecticut, 06810, United States

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Lewes, Delaware, 19958, United States

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Aventura, Florida, 33180, United States

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Boynton Beach, Florida, 33472, United States

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DeBary, Florida, 32713, United States

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Palm Harbor, Florida, 34684, United States

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Pinellas Park, Florida, 33781, United States

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Tampa, Florida, 33609, United States

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Venice, Florida, 34292, United States

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Vero Beach, Florida, 32960, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30033, United States

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Duluth, Georgia, 30096, United States

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Gainesville, Georgia, 30501, United States

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Marietta, Georgia, 30060, United States

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Stockbridge, Georgia, 30281, United States

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Eagle, Idaho, 83616, United States

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Idaho Falls, Idaho, 83404, United States

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Peoria, Illinois, 61602, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46227, United States

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Shawnee Mission, Kansas, 66218, United States

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Owensboro, Kentucky, 42303, United States

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Worcester, Massachusetts, 01605, United States

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Bingham Farms, Michigan, 48025, United States

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Flowood, Mississippi, 39232, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89123, United States

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Albuquerque, New Mexico, 87108, United States

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Brooklyn, New York, 11201, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28210, United States

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Sanford, North Carolina, 27330, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44109, United States

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Tulsa, Oklahoma, 74135, United States

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Erie, Pennsylvania, 16508, United States

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Phoenixville, Pennsylvania, 19460, United States

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Pottstown, Pennsylvania, 19464, United States

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Columbia, South Carolina, 29204, United States

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Greenville, South Carolina, 29601, United States

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Myrtle Beach, South Carolina, 29572, United States

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Watertown, South Dakota, 57201, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78731, United States

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Houston, Texas, 77090, United States

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Lubbock, Texas, 79424, United States

Location

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Mesquite, Texas, 75150, United States

Location

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Nassau Bay, Texas, 77058, United States

Location

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North Richland Hills, Texas, 76180, United States

Location

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San Antonio, Texas, 78215, United States

Location

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Waco, Texas, 76708, United States

Location

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Racine, Wisconsin, 53406, United States

Location

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Buenos Aires, C1280AEB, Argentina

Location

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Córdoba, X5016KEH, Argentina

Location

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Luján, 6700, Argentina

Location

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Mar del Plata, B7600FZN, Argentina

Location

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Quilmes, B1878DVC, Argentina

Location

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San Juan, 5400, Argentina

Location

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San Miguel de Tucumán, 4000, Argentina

Location

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Campbelltown, New South Wales, 2560, Australia

Location

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Herston, Queensland, 4029, Australia

Location

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Malvern East, 3145, Australia

Location

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Campinas, 13059-000, Brazil

Location

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Caxias do Sul, 95070-560, Brazil

Location

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Curitiba, 80060-240, Brazil

Location

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Fortaleza, 60150-170, Brazil

Location

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Goiânia, 74110-120, Brazil

Location

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Juiz de Fora, 36010-570, Brazil

Location

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Rio de Janeiro, 20551-030, Brazil

Location

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São Paulo, 09090780, Brazil

Location

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Burgas, 8000, Bulgaria

Location

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Pleven, 5800, Bulgaria

Location

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Plovdiv, 4003, Bulgaria

Location

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Rousse, 7002, Bulgaria

Location

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Sevlievo, 5400, Bulgaria

Location

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Sofia, 1784, Bulgaria

Location

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Varna, 9000, Bulgaria

Location

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Bogotá, Colombia

Location

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Medellín, Colombia

Location

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Opatija, 51410, Croatia

Location

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Osijek, 31000, Croatia

Location

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Rijeka, 51 000, Croatia

Location

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Baja, 6500, Hungary

Location

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Balassagyarmat, 2660, Hungary

Location

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Budapest, 1095, Hungary

Location

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Debrecen, 4012, Hungary

Location

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Esztergom, 2500, Hungary

Location

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Kiskunhalas, 6400, Hungary

Location

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Sátoraljaújhely, 3980, Hungary

Location

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Szikszó, 3800, Hungary

Location

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Veszprém, 8200, Hungary

Location

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Ahmedabad, 3800015, India

Location

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Bangalore, 5600092, India

Location

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Chennai, 600100, India

Location

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Hyderabaad, 500082, India

Location

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Jaipur, 302019, India

Location

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Lucknow, 226 014, India

Location

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Mysore, 570023, India

Location

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Nellore, 524003, India

Location

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New Delhi, 110 076, India

Location

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Secunderabad, 500 003, India

Location

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Surat, 395003, India

Location

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Aichi, 460-0001, Japan

Location

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Chiba, 284-0003, Japan

Location

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Fukuoka, 807-8555, Japan

Location

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Gunma, 370-0053, Japan

Location

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Hokkaido, 060-8604, Japan

Location

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Hyōgo, 650-0017, Japan

Location

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Ibaraki, 305-8576, Japan

Location

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Ibaraki, 316-0035, Japan

Location

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Japan, 104-8560, Japan

Location

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Kagoshima, 891-0133, Japan

Location

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Kanagawa, 252-0392, Japan

Location

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Kumamoto, 861-8520, Japan

Location

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Mie, 514-1101, Japan

Location

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Miyagi, 982-0032, Japan

Location

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Miyazaki, 880-0122, Japan

Location

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Nagano, 380-8582, Japan

Location

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Nagasaki, 857-1195, Japan

Location

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Nara, 634-0007, Japan

Location

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Ohita, 874-0011, Japan

Location

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Okayama, 710-0016, Japan

Location

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Osaka, 586-8521, Japan

Location

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Saga, 843-0393, Japan

Location

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Saitama, 337-0012, Japan

Location

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Sapporo, 060-8648, Japan

Location

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Tokushima, 770-8503, Japan

Location

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Tokyo, 185-0012, Japan

Location

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Toyama, 933-0874, Japan

Location

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Klaipedos, 92288, Lithuania

Location

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Vilnius, LT-08661, Lithuania

Location

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Kota Bharu, 15586, Malaysia

Location

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Perak, 30990, Malaysia

Location

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Putrajaya, 62250, Malaysia

Location

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Sarawak, 93586, Malaysia

Location

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Aguascalientes, 20203, Mexico

Location

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Barrio San Mateo, 52140, Mexico

Location

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Chihuahua City, 31000, Mexico

Location

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Guadalajara, 44690, Mexico

Location

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Mexicali, 21100, Mexico

Location

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Mexico City, 14050, Mexico

Location

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Monterrey, 64460, Mexico

Location

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Morelia, 58070, Mexico

Location

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Querétaro, 76000, Mexico

Location

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San Luis Potosí City, 78200, Mexico

Location

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Tijuana, 22010, Mexico

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Hamilton, 3204, New Zealand

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Rotorua, 3010, New Zealand

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Tauranga, 3140, New Zealand

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Timaru, New Zealand

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Bydgoszcz, 85-168, Poland

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Działdowo, 13-200, Poland

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Elblag, 82-300, Poland

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Gdynia, 81-384, Poland

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Lublin, 20-607, Poland

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Płock, 09-400, Poland

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Torun, 87-100, Poland

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Warsaw, 01-192, Poland

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Włoszczowa, 29-100, Poland

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Brasov, 500365, Romania

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Cluj-Napoca, 400130, Romania

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Iași, 700656, Romania

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Ploieşti, 100337, Romania

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Barnaul, 656038, Russia

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Kazan', 420029, Russia

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Kemerovo, 650066, Russia

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Khanty-Mansiysk, 628012, Russia

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Moscow, 125299, Russia

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Novosibirsk, 630047, Russia

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Petrozavodsk, 185019, Russia

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Ryazan, 390026, Russia

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Saint Petersburg, 194291, Russia

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Saratov, 410002, Russia

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Stavropol, 355017, Russia

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Voronezh, 394066, Russia

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Yaroslavl, 150062, Russia

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Bratislava, 84231, Slovakia

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Dunajská Streda, 929 01, Slovakia

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Piešťany, 921 12, Slovakia

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Benoni, 1500, South Africa

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Bloemfontein, 9301, South Africa

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Cape Town, 7925, South Africa

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Durban, 4001, South Africa

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Limpopo, 0380, South Africa

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Pretoria, 0084, South Africa

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Somerset West, 7130, South Africa

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Stellenbosch, 7600, South Africa

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Busan, 602-715, South Korea

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Daegu, 700-721, South Korea

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Daejeon, 301-721, South Korea

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Incheon, 400-711, South Korea

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Seongnam-si, 463-707, South Korea

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Seoul, 143-729, South Korea

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Suwon, 442-721, South Korea

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Colombo, Sri Lanka

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Galle, Sri Lanka

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Kalubowila, Sri Lanka

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Nugegoda, Sri Lanka

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Chiayi City, 613, Taiwan

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Keelung, 204, Taiwan

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Kuei Shan Hsiang, 33305, Taiwan

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Niao Sung Hsiang, 833, Taiwan

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Taichung, 404, Taiwan

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Taipei, 112, Taiwan

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Dnipropetrovsk, 49008, Ukraine

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Donetsk, 83045, Ukraine

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Kharkiv, 61178, Ukraine

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Kyiv, 03151, Ukraine

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Odesa, 65026, Ukraine

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Poltava, 36038, Ukraine

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Vinnytsia, 21018, Ukraine

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Related Publications (1)

• Smolen JS, Weinblatt ME, van der Heijde D, Rigby WF, van Vollenhoven R, Bingham CO 3rd, Veenhuizen M, Gill A, Zhao F, Komocsar WJ, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-B-cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study. Ann Rheum Dis. 2015 Aug;74(8):1567-70. doi: 10.1136/annrheumdis-2014-207090. Epub 2015 Apr 14.

  PMID: 25873635 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tabalumab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This study has been terminated not based on safety concerns, but due to insufficient efficacy. Early termination led to lower than expected enrollment and was responsible for the large number of discontinuation reason as Sponsor Decision.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 9, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2014
• Last Updated: May 8, 2018
• Results First Posted: May 8, 2018

Record last verified: 2018-05

Locations

IN (11); KR (7); MY (4); RU (13); AU (3); NZ (4); BU (7); SR (4); TW (6); BR (8); CR (3); LI (2); US (75); SL (3); AR (7); RO (4); PL (9); ZA (8); HU (9); CO (2); UA (7); JP (27); ME (11)