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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01198002
First received: September 8, 2010
Last updated: July 19, 2013
Last verified: July 2013

September 8, 2010
July 19, 2013
December 2010
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01198002 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate
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)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: LY2127399
    Administered Subcutaneously
  • Drug: Placebo every 2 weeks
    Administered Subcutaneously
  • Drug: Placebo every 4 weeks
    Administered Subcutaneously
  • 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.

    Interventions:
    • Drug: LY2127399
    • Drug: Placebo every 4 weeks
  • 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.

    Intervention: Drug: LY2127399
  • 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.

    Interventions:
    • Drug: LY2127399
    • Drug: Placebo every 2 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
990
January 2014
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Brazil,   Bulgaria,   Colombia,   Croatia,   Hungary,   India,   Japan,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   New Zealand,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Sri Lanka,   Taiwan,   Ukraine
 
NCT01198002
11352, H9B-MC-BCDM, CTRI/2011/07/001870
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP