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A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFα Inhibitor Therapy

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00689728
First received: June 2, 2008
Last updated: December 9, 2010
Last verified: December 2010
  Purpose
The purpose of this study is to explore whether LY2127399 is effective in relieving signs and symptoms of RA in patients with a history of inadequate response or intolerance to at least 1 TNFα inhibitor therapy. Examples of these TNFα inhibitor therapies that are currently on the market include Enbrel® (etanercept), Remicade® (infliximab), and Humira® (adalimumab).

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFα Inhibitor Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To assess LY2127399 efficacy using the ACR50 scale [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • To evaluate LY2127399 safety and tolerability compared to placebo [ Time Frame: 24 weeks ]
  • To evaluate LY2127399 pharmacokinetics and pharmacodynamics [ Time Frame: 24 weeks ]
  • To evaluate the impact of LY2127399 as measured by patient outcomes [ Time Frame: 24 weeks ]

Estimated Enrollment: 100
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
30 mg LY2127399
Biological: LY2127399
30 mg of LY2127399 will be administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks.
Experimental: 2
80 mg LY2127399
Biological: LY2127399
80 mg of LY2127399 will be administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks.
Placebo Comparator: 3
placebo
Drug: Placebo
Placebo will be administered as a single IV infusion over 30 minutes at 0, 3, and 6 weeks.

  Eligibility

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 approval
  • Women must not be at risk to become pregnant during study participation
  • Diagnosis of Rheumatoid Arthritis
  • Active Rheumatoid Arthritis
  • Current, regular use of Methotrexate, at a stable dose
  • Have been on at least 1 biologic TNFα inhibitor therapy and either failed or were intolerant to treatment
  • Other criteria to be reviewed by study doctor

Exclusion Criteria:

  • Use of excluded medications (reviewed by study doctor)
  • Have medical findings which, in the opinion of the study doctor, put patient at an unacceptable risk for participation in the study
  • Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation
  • Evidence of tuberculosis
  • Have systemic inflammatory condition other than RA, such as juvenile RA, seronegative spondyloarthropathy, Crohn's disease, ulcerative colitis, or psoriatic arthritis.
  • Other criteria to be reviewed by study doctor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689728

  Show 45 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00689728     History of Changes
Other Study ID Numbers: 11351
H9B-MC-BCDG ( Other Identifier: Eli Lilly and Company )
Study First Received: June 2, 2008
Last Updated: December 9, 2010

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

ClinicalTrials.gov processed this record on May 23, 2017