A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX M)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01198002
First received: September 8, 2010
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: LY2127399
Drug: Placebo every 2 weeks
Drug: Placebo every 4 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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 (FLEX M)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of patients with American College of Rheumatology 20% response (ACR20) at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS) [ Time Frame: Baseline, 52 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Disease Activity Score C-Reactive Protein (DAS28-CRP) [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scores [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Brief Fatigue Inventory (BFI) individual items and impact score [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in duration of morning stiffness (minutes) [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with Major Clinical Response (MCR) during 52 weeks [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with change from baseline in mTSS less than or equal to 0 [ Time Frame: 24 weeks, 52 weeks, 100 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in B cell subset counts [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Population Pharmacokinetics (PK) [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients developing anti-LY2127399 antibodies [ Time Frame: Baseline through 100 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in Brief Pain Inventory Short Form (BPI-sf) individual items and interference scores [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with structural inhibition at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mTSS [ Time Frame: Baseline, 24 weeks, 100 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in serum immunoglobulin (Ig) levels [ Time Frame: Baseline, 24 weeks, 52 weeks, 100 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in joint space narrowing score and bone erosions score (components of mTSS) [ Time Frame: Baseline, 24 weeks, 52 weeks, 100 weeks ] [ Designated as safety issue: No ]
  • Mean percent improvement in ACR N [ Time Frame: 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Tender Joint Count (68 joint count) [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Swollen Joint Count (66 joint count) [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Patient's Assessment of Pain (VAS) [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Patient's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Physician's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to Week 52 in HAQ-DI [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in absolute B cell counts [ Time Frame: Baseline, 24 weeks, 52 weeks, 100 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of patients with ACR20 at Week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to ACR20 response [ Time Frame: Baseline through 24 and 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CRP [ Time Frame: Baseline, 24 weeks, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 990
Study Start Date: December 2010
Study Completion Date: January 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 120 mg LY2127399

Given every 4 weeks for 100 weeks. Patients receive a 240mg loading dose when initiating treatment. During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.

After 16 weeks, non-responders will receive 90 mg every 2 weeks.

Drug: LY2127399
Administered Subcutaneously
Drug: Placebo every 4 weeks
Administered Subcutaneously
Experimental: 90 mg LY2127399

Given every 2 weeks for 100 weeks. Patients receive a 180 mg loading dose when initiating treatment.

After 16 weeks, non-responders will continue to receive 90 mg every 2 weeks.

Drug: LY2127399
Administered Subcutaneously
Placebo Comparator: Placebo

Given every 2 weeks for 52 weeks, and then patients are randomized to receive one of the 2 doses of LY2127399.

After 16 weeks, non-responders will receive 90 mg every 2 weeks.

Drug: LY2127399
Administered Subcutaneously
Drug: Placebo every 2 weeks
Administered Subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
  • 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 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
  • History of the use of rituximab, any other B cell targeted biotherapy, or denosumab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198002

  Hide Study Locations
Locations
United States, Alabama
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United States, Arizona
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United States, Arkansas
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Columbia, South Carolina, United States, 29204
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Greenville, South Carolina, United States, 29601
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Myrtle Beach, South Carolina, United States, 29572
United States, South Dakota
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Watertown, South Dakota, United States, 57201
United States, Tennessee
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Memphis, Tennessee, United States, 38119
United States, Texas
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Austin, Texas, United States, 78731
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Houston, Texas, United States, 77090
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Lubbock, Texas, United States, 79424
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Mesquite, Texas, United States, 75150
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Nassau Bay, Texas, United States, 77058
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North Richland Hills, Texas, United States, 76180
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San Antonio, Texas, United States, 78215
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Waco, Texas, United States, 76708
United States, Wisconsin
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Racine, Wisconsin, United States, 53406
Argentina
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Buenos Aires, Argentina, C1280AEB
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Córdoba, Argentina, X5016KEH
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Lujan, Argentina, 6700
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Mar Del Plata, Argentina, B7600FZN
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Quilmes, Argentina, B1878DVC
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San Juan, Argentina, 5400
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Tucuman, Argentina, 4000
Australia, New South Wales
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Campbelltown, New South Wales, Australia, 2560
Australia, Queensland
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Herston, Queensland, Australia, 4029
Australia
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Malvern East, Australia, 3145
Brazil
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Campinas, Brazil, 13059-000
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Caxias Do Sul, Brazil, 95070-560
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Curitiba, Brazil, 80060-240
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Fortaleza, Brazil, 60150-170
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Goiania, Brazil, 74110-120
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Juiz De Fora, Brazil, 36010-570
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Rio De Janeiro, Brazil, 20551-030
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São Paulo, Brazil, 09090780
Bulgaria
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Burgas, Bulgaria, 8000
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4003
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Rousse, Bulgaria, 7002
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Sevlievo, Bulgaria, 5400
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Sofia, Bulgaria, 1784
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Varna, Bulgaria, 9000
Colombia
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Bogota, Colombia
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Medellin, Colombia
Croatia
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Opatija, Croatia, 51410
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Osijek, Croatia, 31000
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Rijeka, Croatia, 51 000
Hungary
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Baja, Hungary, 6500
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Balassagyarmat, Hungary, 2660
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Budapest, Hungary, 1095
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Debrecen, Hungary, 4012
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Esztergom, Hungary, 2500
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Kiskunhalas, Hungary, 6400
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Satoraljaujhely, Hungary, 3980
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Szikszo, Hungary, 3800
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Veszprem, Hungary, 8200
India
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Ahmedabad, India, 3800015
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Bangalore, India, 5600092
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Chennai, India, 600100
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Hyderabaad, India, 500082
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Jaipur, India, 302019
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Lucknow, India, 226 014
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Mysore, India, 570023
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Nellore, India, 524003
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New Delhi, India, 110 076
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Secunderabad, India, 500 003
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Surat, India, 395003
Japan
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Aichi, Japan, 460-0001
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Chiba, Japan, 284-0003
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Fukuoka, Japan, 807-8555
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Gunma, Japan, 370-0053
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Hokkaido, Japan, 060-8604
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Hyogo, Japan, 650-0017
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Ibaragi, Japan, 316-0035
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Ibaraki, Japan, 305-8576
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Japan, Japan, 104-8560
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Kagoshima, Japan, 891-0133
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Kanagawa, Japan, 252-0392
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Kumamoto, Japan, 861-8520
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Mie, Japan, 514-1101
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Miyagi, Japan, 982-0032
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Miyazaki, Japan, 880-0122
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Nagano, Japan, 380-8582
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Nagasaki, Japan, 857-1195
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Nara, Japan, 634-0007
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Ohita, Japan, 874-0011
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Okayama, Japan, 710-0016
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Osaka, Japan, 586-8521
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Saga, Japan, 843-0393
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Saitama, Japan, 337-0012
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Sapporo-Shi, Japan, 060-8648
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Tokushima, Japan, 770-8503
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Tokyo, Japan, 185-0012
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Toyama, Japan, 933-0874
Korea, Republic of
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Busan, Korea, Republic of, 602-715
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Daegu, Korea, Republic of, 700-721
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Daejeon, Korea, Republic of, 301-721
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Incheon, Korea, Republic of, 400-711
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Seongnam-Si, Korea, Republic of, 463-707
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Seoul, Korea, Republic of, 143-729
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Suwon-City, Korea, Republic of, 442-721
Lithuania
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Klaipedos, Lithuania, 92288
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Vilnius, Lithuania, LT-08661
Malaysia
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Kota Bahru, Malaysia, 15586
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Perak, Malaysia, 30990
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Putrajaya, Malaysia, 62250
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Sarawak, Malaysia, 93586
Mexico
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Aguascalientes, Mexico, 20203
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Barrio San Mateo, Mexico, 52140
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Chihuahua, Mexico, 31000
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Guadalajara, Mexico, 44690
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Mexicali, Mexico, 21100
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Mexico City, Mexico, 14050
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Monterrey, Mexico, 64460
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Morelia, Mexico, 58070
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Queretaro, Mexico, 76000
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San Luis Potosi, Mexico, 78200
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Tijuana, Mexico, 22010
New Zealand
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Hamilton, New Zealand, 3204
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Rotorua, New Zealand, 3010
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Tauranga, New Zealand, 3140
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Timaru, New Zealand
Poland
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Bydgoszcz, Poland, 85-168
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Dzialdowo, Poland, 13-200
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Elblag, Poland, 82-300
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Gdynia, Poland, 81-384
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Lublin, Poland, 20-607
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Plock, Poland, 09-400
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Torun, Poland, 87-100
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Warsaw, Poland, 01-192
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Wloszczowa, Poland, 29-100
Romania
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Brasov, Romania, 500365
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Cluj-Napoca, Romania, 400130
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Iasi, Romania, 700656
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Ploiesti, Romania, 100337
Russian Federation
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Barnaul, Russian Federation, 656038
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Kazan, Russian Federation, 420029
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Kemerovo, Russian Federation, 650066
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Khanty-Mansiysk, Russian Federation, 628012
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Moscow, Russian Federation, 125299
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Novosibirsk, Russian Federation, 630047
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Petrozavodsk, Russian Federation, 185019
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Ryazan, Russian Federation, 390026
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Saint Petersburg, Russian Federation, 194291
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Saratov, Russian Federation, 410002
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Stavropol, Russian Federation, 355017
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Voronezh, Russian Federation, 394066
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Yaroslavl, Russian Federation, 150062
Slovakia
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Bratislava, Slovakia, 84231
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Dunajska Streda, Slovakia, 929 01
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Piestany, Slovakia, 921 12
South Africa
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Benoni, South Africa, 1500
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Bloemfontein, South Africa, 9301
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Cape Town, South Africa, 7925
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Durban, South Africa, 4001
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Limpopo, South Africa, 0380
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Pretoria, South Africa, 0084
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Somerset West, South Africa, 7130
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Stellenbosch, South Africa, 7600
Sri Lanka
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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
Taiwan
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Chiayi, Taiwan, 613
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Keelung, Taiwan, 204
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Kuei Shan Hsiang, Taiwan, 33305
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Niao Sung Hsiang, Taiwan, 833
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Taichung, Taiwan, 404
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Taipei, Taiwan, 112
Ukraine
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Dnipropetrovsk, Ukraine, 49008
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Donetsk, Ukraine, 83045
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Kharkiv, Ukraine, 61178
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Kyiv, Ukraine, 03151
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Odesa, Ukraine, 65026
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Poltava, Ukraine, 36038
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Vinnytsya, Ukraine, 21018
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01198002     History of Changes
Other Study ID Numbers: 11352, H9B-MC-BCDM, CTRI/2011/07/001870
Study First Received: September 8, 2010
Last Updated: March 31, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Croatia: Ministry of Health and Social Care
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Japan: Ministry of Health, Labor and Welfare
Lithuania: State Medicine Control Agency - Ministry of Health
Malaysia: Ministry of Health
Mexico: Secretaria de Salud
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: The Central Register of Clinical Trials
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sri Lanka: Ministry of Healthcare & Nutrition
Taiwan: Department of Health
Taiwan: Center for Drug Evaluation
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Eli Lilly and Company:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014