A Rheumatoid Arthritis Study in Patients (FLEX O)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01202760
First received: September 14, 2010
Last updated: August 19, 2013
Last verified: August 2013

September 14, 2010
August 19, 2013
January 2011
December 2012   (final data collection date for primary outcome measure)
Percentage of patients with American College of Rheumatology 20% response (ACR20) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01202760 on ClinicalTrials.gov Archive Site
  • Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean percent improvement in ACR-N [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Tender Joint Count (68 joint count) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Swollen Joint Count (66 joint count) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Patient's Assessment of Pain (VAS) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Patient's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Physician's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Disease Activity Score-C-Reactive Protein (DAS28-CRP) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain and summary scores [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Time to ACR20 response [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in absolute B cell counts [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 24 weeks in serum immunoglobulin (Ig) levels [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
  • Population Pharmacokinetics (PK) [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients developing anti-LY2127399 antibodies [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 24 weeks in CRP [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with American College of Rheumatology 50% (ACR50) and 70% (ACR70) response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Mean percent improvement in ACR-N [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Tender Joint Count (68 joint count) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Swollen Joint Count (66 joint count) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Patient's Assessment of Pain (VAS) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Patient's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Physician's Global Assessment of Disease Activity (VAS) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Disease Activity Score-C-Reactive Protein (DAS28-CRP) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR) response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain and summary scores [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Time to ACR20 response [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks in absolute B cell counts [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 24 weeks in serum immunoglobulin (Ig) levels [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
  • Population Pharmacokinetics (PK) [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients developing anti-LY2127399 antibodies [ Time Frame: Baseline through 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Rheumatoid Arthritis Study in Patients
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy.

This study is comprised of 2 periods:

Period 1 - 24 week blinded treatment

Period 2 - 48 week post treatment follow up

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: LY2127399
    Administered Subcutaneously
  • Drug: Placebo every 4 weeks
    Administered Subcutaneously
  • Drug: Placebo every 2 weeks
    Administered Subcutaneously
  • Experimental: 120 mg LY2127399

    Given every 4 weeks for 24 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 24 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 24 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.
 
Completed
1002
July 2013
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
  • Global Assessment of Disease Activity visual analog scale (VAS)greater than or equal to 20/100 mm
  • If on one or more conventional DMARDs at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
  • 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
  • Use of biologic DMARD concurrently or recently
  • History of a serious reaction to other biological DMARDs
  • Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan,   United States,   Argentina,   Australia,   Bulgaria,   Colombia,   Croatia,   Hungary,   India,   Ukraine,   Korea, Republic of,   Lithuania,   Malaysia,   Mexico,   New Zealand,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Sri Lanka,   Taiwan
 
NCT01202760
12978, H9B-MC-BCDO, CTRI/2011/07/001867
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
August 2013

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