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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01198002
Recruitment Status : Terminated (Terminated not based on safety concerns, but due to insufficient efficacy.)
First Posted : September 9, 2010
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
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 3 periods:

Period 1: 52-week blinded treatment

Period 2: additional 48-week unblinded treatment

Period 3: 48-week post-treatment follow-up


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: LY2127399 Drug: Placebo Q2W Drug: Placebo Q4W Drug: Methotrexate Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1041 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 120 milligrams (mg) LY2127399

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
Administered Subcutaneously (SC)

Drug: Placebo Q4W
Administered SC

Drug: Methotrexate
Methotrexate is a background therapy.

Experimental: 90 mg LY2127399

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
Administered Subcutaneously (SC)

Drug: Methotrexate
Methotrexate is a background therapy.

Placebo Comparator: Placebo

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
Administered Subcutaneously (SC)

Drug: Placebo Q2W
Administered SC

Drug: Methotrexate
Methotrexate is a background therapy.




Primary Outcome Measures :
  1. Percentage of Participants With American College of Rheumatology 20% Response (ACR20) at Week 24 [ Time Frame: Baseline through 24 weeks ]
    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.

  2. Change From Baseline to Week 52 in Van Der Heijde Modified Total Sharp Score (mTSS) [ Time Frame: Baseline, 52 Weeks ]
    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.

  3. Change From Baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response [ Time Frame: Baseline through 24 weeks and 52 weeks ]
    ACR Responder Index: Composite of clinical, laboratory, and functional measures of RA. ACR50 Responder: had ≥50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and ≥50% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No.) of ACR50 responders) / (No. of Pts treated) * 100. ACR70 Responder: had ≥70% improvement from baseline in both TJ and SJ counts and ≥70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response= (No. of ACR70 responders) / (No. of Pts treated) * 100. All NR at Week 16 as well as all Pts who discontinued study treatment at any time for any reason were defined as NR starting at that time-point and going forward, including Weeks 24 and 52 endpoints.

  2. Change From Baseline in Disease Activity Score Based on 28 Joint Count and C-Reactive Protein Level (DAS28-CRP) [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  3. Percentage of Participants With DAS28-CRP Based European League Against Rheumatism (EULAR) Response [ Time Frame: Baseline through 24 weeks and 52 weeks ]
    EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or NR based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100.

  4. Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey Domain Scores and Summary Scores [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, 2 component scores (CS), physical CS (PCS) and mental CS (MCS). Domain scores were calculated by summing each item for each domain and transforming scores into a 0-100 scale. Higher scores indicated better health status. If < 50% of the questions within a domain were answered, raw scores were not calculated. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. Both PCS and MCS range from 0-100. Higher score indicated better mental or physical health. LS means were calculated using ANCOVA with treatment, region as fixed factors and baseline as a covariate.

  5. Change From Baseline in Brief Fatigue Inventory (BFI) Individual Items and Impact Score [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    The BFI is a brief participant-reported questionnaire for the rapid assessment of fatigue severity and the impact of fatigue on daily functioning in the past 24 hours. The BFI contains 10 items; however, Item 1 is not included in the scoring of the scale as it asks about usual fatigue over the past week with the participant answering 'yes' or 'no'. The remaining 9 items assess fatigue severity (3 items) and impact of fatigue on daily functioning (6 items) using an 11-point numeric scale, with 0=no fatigue and 10=fatigue as bad as you can imagine. The fatigue impact subscale score is the average of the non-missing responses to 6 items: general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life. If more than 3 items within the fatigue impact subscale were not answered by a participant, the subscale is set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  6. Change From Baseline in Duration of Morning Stiffness (Minutes) [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    The Investigator asks participants about the duration of their morning stiffness (in minutes) in and around the joints and records the duration. The Investigator should ask the participants about duration of morning stiffness on the day prior to the study visit to capture actual symptoms. If morning stiffness duration is longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  7. Change From Baseline in Brief Pain Inventory Short Form (BPI-SF) Individual Items and Interference Scores [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    The BPI-SF is a self-reported scale that measures the severity of pain based on the worst pain, least pain, average pain experienced during the past 24-hours and pain based on the pain right now with scores ranging from 0 (no pain) to 10 (pain as severe as you can imagine). Pain interference score is the average of the responses in past 24-hours to 7 items: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life [each item scored from 0 (does not interfere) to 10 (completely interferes)]. If more than 3 items of the Pain Interference Score are not answered by a participant, the score were set to missing. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  8. Percentage of Participants With Major Clinical Response (MCR) During 52 Weeks [ Time Frame: Baseline through 52 weeks ]
  9. Percentage of Participants With Change From Baseline in mTSS Less Than or Equal to (≤) 0 [ Time Frame: Baseline through 24 weeks ]
    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]). Percentage of participants = (number of participants with mTSS ≤0 at Week 24) / (total number of participants analyzed in the group) * 100.

  10. Change From Baseline to Week 52 in B Cell Subset Counts [ Time Frame: Baseline, 52 weeks ]
    B cell subset counts are: cluster designation (CD)19+ B cell counts, Immature/transitional [CD19+immunoglobulin D (IgD)-CD27-], Mature naïve (CD19+IgD+CD27-), Non-switched memory (CD19+IgD+CD27+) and Memory (CD19+IgD-CD27+). A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  11. Population Pharmacokinetics (PK): Constant Clearance [ Time Frame: Baseline through 52 weeks ]
    Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum.

  12. Percentage of Participants Developing Anti-LY2127399 Antibodies [ Time Frame: Baseline through 52 weeks ]
    Participants with treatment-emergent anti-drug antibodies (ADA) were participants who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Percentage of participants with ADA=(number of participants with treatment-emergent ADA) / (number of participants assessed) * 100.

  13. Percentage of Participants With No Structural Progression at Week 52 [ Time Frame: Baseline through 52 weeks ]
    No structural progression is defined as the change in mTSS from baseline ≤0. 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]). Percentage of participants=(number of participants with mTSS ≤0 at Week 52) / (total number of participants analyzed in the group) * 100.

  14. Change From Baseline to Week 24 in mTSS [ Time Frame: Baseline, 24 weeks ]
    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]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  15. Change From Baseline in Serum Immunoglobulin (Ig) Levels [ Time Frame: Baseline, 52 weeks ]
    Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Change from baseline serum immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in Ig levels. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  16. Change From Baseline in Joint Space Narrowing Score and Bone Erosions Score (Components of mTSS) [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    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]). LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  17. American College of Rheumatology Percent Improvement (ACR-N) [ Time Frame: Baseline through 24 weeks and 52 weeks ]
    ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in RA that characterizes percentage (%) of improvement in disease activity from baseline based on ACR core set. This index was calculated as minimum of either a) % change in TJ count, b) % change in SJ count, or c) the median % change of remaining 5 ACR core criteria: If ≥3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater % improvement) and negative scores indicate a decline. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline DAS28-CRP as a covariate.

  18. Change From Baseline in Tender Joint Count (68 Joint Count) [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  19. Change From Baseline in Swollen Joint Count (66 Joint Count) [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  20. Change From Baseline in Participant's Assessment of Pain [Visual Analog Scale (VAS)] [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    Participant's assessment of their current arthritis pain using VAS ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain 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.

  21. Change From Baseline in Participant's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    Participant's assessment of their current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity 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.

  22. Change From Baseline in Physician's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    Physician's assessment of the participant's current arthritis disease activity using VAS ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity 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.

  23. Change From Baseline to Week 52 in HAQ-DI [ Time Frame: Baseline, 52 weeks ]
    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.

  24. Change From Baseline to Week 52 in Absolute B Cell Counts [ Time Frame: Baseline, 52 weeks ]
    Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. A positive or negative change indicated an increase or decrease, respectively in B cell count. LS means were calculated using ANCOVA with treatment and region as fixed factors and baseline as a covariate.

  25. Percentage of Participants With ACR20 at Week 52 [ Time Frame: Baseline through 52 weeks ]
    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, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and 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 52 endpoint.

  26. Time to ACR20 Response [ Time Frame: Baseline through 52 weeks ]
    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, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP. The Kaplan-Meier was used to estimate time to ACR20 response over the Treatment Period (52 weeks). Time to ACR20 response = (Date of the first post-baseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7. Week 16 NR are counted as responders if they responded prior to Week 16. Otherwise, they are censored at the date of the Week 16 injection. All participants ongoing at Week 52 and had not yet responded are censored at the date of the Week 52 visit.

  27. Change From Baseline in CRP [ Time Frame: Baseline, 24 weeks and 52 weeks ]
    CRP is an indicator of inflammation. A negative change 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.


Other Outcome Measures:
  1. Number of Participants Who Died During Post-Treatment Follow-Up Period [ Time Frame: Discontinuation from study treatment up to 48 weeks during follow-up period ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198002


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Locations
United States, Alabama
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Birmingham, Alabama, United States, 35216
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Huntsville, Alabama, United States, 35801
United States, Arizona
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Paradise Valley, Arizona, United States, 85253
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85018
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Scottsdale, Arizona, United States, 85251
United States, Arkansas
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Hot Springs, Arkansas, United States, 71913
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Little Rock, Arkansas, United States, 72205
United States, California
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Escondido, California, United States, 92027
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Fresno, California, United States, 93720
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Hemet, California, United States, 92543
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La Jolla, California, United States, 92037
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La Mesa, California, United States, 91942
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Sacramento, California, United States, 95825
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Torrance, California, United States, 90505
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Tustin, California, United States, 92780
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Upland, California, United States, 91786
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Wildomar, California, United States, 92595
United States, Colorado
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Colorado Springs, Colorado, United States, 80910
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Denver, Colorado, United States, 80209
United States, Connecticut
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Danbury, Connecticut, United States, 06810
United States, Delaware
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Lewes, Delaware, United States, 19958
United States, Florida
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Aventura, Florida, United States, 33180
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Boynton Beach, Florida, United States, 33472
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DeBary, Florida, United States, 32713
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Palm Harbor, Florida, United States, 34684
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Pinellas Park, Florida, United States, 33781
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Tampa, Florida, United States, 33609
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Venice, Florida, United States, 34292
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Vero Beach, Florida, United States, 32960
United States, Georgia
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Atlanta, Georgia, United States, 30342
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Decatur, Georgia, United States, 30033
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Duluth, Georgia, United States, 30096
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Gainesville, Georgia, United States, 30501
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Marietta, Georgia, United States, 30060
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Stockbridge, Georgia, United States, 30281
United States, Idaho
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Eagle, Idaho, United States, 83616
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Peoria, Illinois, United States, 61602
United States, Indiana
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Evansville, Indiana, United States, 47714
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Indianapolis, Indiana, United States, 46227
United States, Kansas
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Shawnee Mission, Kansas, United States, 66218
United States, Kentucky
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Owensboro, Kentucky, United States, 42303
United States, Massachusetts
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Worcester, Massachusetts, United States, 01605
United States, Michigan
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Bingham Farms, Michigan, United States, 48025
United States, Mississippi
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Flowood, Mississippi, United States, 39232
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Jackson, Mississippi, United States, 39202
United States, Missouri
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Saint Louis, Missouri, United States, 63141
United States, Nebraska
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Omaha, Nebraska, United States, 68134
United States, Nevada
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Las Vegas, Nevada, United States, 89123
United States, New Mexico
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Albuquerque, New Mexico, United States, 87108
United States, New York
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Brooklyn, New York, United States, 11201
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Syracuse, New York, United States, 13210
United States, North Carolina
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Charlotte, North Carolina, United States, 28210
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Sanford, North Carolina, United States, 27330
United States, Ohio
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Cincinnati, Ohio, United States, 45242
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Cleveland, Ohio, United States, 44109
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
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Erie, Pennsylvania, United States, 16508
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Phoenixville, Pennsylvania, United States, 19460
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Pottstown, Pennsylvania, United States, 19464
United States, South Carolina
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01198002     History of Changes
Other Study ID Numbers: 11352
H9B-MC-BCDM ( Other Identifier: Eli Lilly and Company )
CTRI/2011/07/001870 ( Registry Identifier: Clinical Trials Registry India )
First Posted: September 9, 2010    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018
Last Verified: May 2018

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
Antibodies, Monoclonal
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
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