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

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: NCT00785928
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : February 15, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
To assess the efficacy of LY2127399 versus placebo using ACR50 response scale at 24 weeks

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: LY2127399 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2008
Primary Completion Date : January 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. To assess LY2127399 efficacy using the ACR 50 response rate at week 24 [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. To evaluate the LY2127399 dose-ACR50 response and the dose-ACR20 response relationship at 24 weeks relative to placebo [ Time Frame: 24 weeks ]
  2. To evaluate LY2127399 safety and tolerability compared to placebo [ Time Frame: 24 weeks ]
  3. 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 ]
  4. To further characterize LY2127399 PK in RA patients on MTX therapy [ Time Frame: 24 weeks ]
  5. 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 ]
  6. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00785928     History of Changes
Other Study ID Numbers: 12409
H9B-MC-BCDH ( Other Identifier: Eli Lilly and Company )
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011

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
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