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A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00785928
First received: November 3, 2008
Last updated: February 11, 2011
Last verified: February 2011
History of Changes

November 3, 2008
February 11, 2011
October 2008
January 2010   (final data collection date for primary outcome measure)
To assess LY2127399 efficacy using the ACR 50 response rate at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00785928 on ClinicalTrials.gov Archive Site
  • To evaluate the LY2127399 dose-ACR50 response and the dose-ACR20 response relationship at 24 weeks relative to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate LY2127399 safety and tolerability compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the potential effect of LY2127399 compared to placebo on patient- reported outcomes as measured by the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To further characterize LY2127399 PK in RA patients on MTX therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the ACR50 response rate, individual components of the ACR core set, DAS 28 change over the 24 week study period. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate the potential effect of LY2127399 compared to placebo on patient- reported outcomes as measured by the Medical Outcomes Study 36 Item Short Form Health Survey (SF-36) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

To assess the efficacy of LY2127399 versus placebo using ACR50 response scale at 24 weeks
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: LY2127399
    subcutaneously q 4 weeks
  • Drug: Placebo
    subcutaneously q 4 wks
  • Experimental: 1
    1 mg LY2127399
    Intervention: Biological: LY2127399
  • Placebo Comparator: 7
    Placebo
    Intervention: Drug: Placebo
  • Experimental: 2
    3 mg LY2127399
    Intervention: Biological: LY2127399
  • Experimental: 3
    10 mg LY2127399
    Intervention: Biological: LY2127399
  • Experimental: 4
    30 mg LY2127399
    Intervention: Biological: LY2127399
  • Experimental: 5
    60mg LY2127399
    Intervention: Biological: LY2127399
  • Experimental: 6
    120mg of LY2127399
    Intervention: Biological: LY2127399
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
December 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have given written informed consent
  • Women must not be at risk to become pregnant during study participation
  • Diagnosis of Rheumatoid Arthritis
  • Current, regular use of Methotrexate, at a stable dose
  • Other criteria to be reviewed by study doctor

Exclusion Criteria:

  • Use of excluded medications(reviewed by study doctor)
  • Have not failed biologic TNFa inhibitor therapy
  • Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
  • Evidence of tuberculosis
  • Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
  • Other criteria to be reviewed by study doctor
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Chile,   Germany,   Hungary,   India,   Mexico,   Poland,   Romania,   Slovakia,   Ukraine
 
NCT00785928
12409, H9B-MC-BCDH
No
Chief Medical Officer, Eli Lilly
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 - 5PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
February 2011

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