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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
  Purpose

To assess the efficacy of LY2127399 versus placebo using ACR50 response scale at 24 weeks


Condition Intervention Phase
Rheumatoid Arthritis
 Biological: LY2127399
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To assess LY2127399 efficacy using the ACR 50 response rate at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 158
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1 mg LY2127399
 Biological: LY2127399
subcutaneously q 4 weeks
Placebo Comparator: 7
Placebo
 Drug: Placebo
subcutaneously q 4 wks
Experimental: 2
3 mg LY2127399
 Biological: LY2127399
subcutaneously q 4 weeks
Experimental: 3
10 mg LY2127399
 Biological: LY2127399
subcutaneously q 4 weeks
Experimental: 4
30 mg LY2127399
 Biological: LY2127399
subcutaneously q 4 weeks
Experimental: 5
60mg LY2127399
 Biological: LY2127399
subcutaneously q 4 weeks
Experimental: 6
120mg of LY2127399
 Biological: LY2127399
subcutaneously q 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785928

  Show 48 Study Locations
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 - 5PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00785928     History of Changes
Other Study ID Numbers: 12409, H9B-MC-BCDH
Study First Received: November 3, 2008
Last Updated: February 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
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 May 16, 2013