Text Size

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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate LY2127399 safety and tolerability compared to placebo [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate LY2127399 pharmacokinetics and pharmacodynamics [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the impact of LY2127399 as measured by patient outcomes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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.
Other Name: LY2127399
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.
Other Name: LY2127399
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
Genders Eligible for Study:   Both
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
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:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00689728     History of Changes
Other Study ID Numbers: 11351, H9B-MC-BCDG
Study First Received: June 2, 2008
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration

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 22, 2013