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A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00308282
First received: March 28, 2006
Last updated: September 17, 2008
Last verified: September 2008
History of Changes

March 28, 2006
September 17, 2008
March 2006
June 2007   (final data collection date for primary outcome measure)
Effectiveness of LY2127399 in treating Rheumatoid Arthritis using the ACR20 scale. [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Effectiveness of LY2127399 in treating Rheumatoid Arthritis using the ACR20 scale at week 24.
Complete list of historical versions of study NCT00308282 on ClinicalTrials.gov Archive Site
  • Safety of repeat doses (3) of LY2127399 through evaluation of laboratory tests, vital signs and electrocardiograms. [ Time Frame: various time points in the study ] [ Designated as safety issue: Yes ]
  • Evaluation of the pharmacokinetics of LY2127399 in patients through blood sample collections. [ Time Frame: various time points in the study ] [ Designated as safety issue: Yes ]
  • Safety of repeat doses (3) of LY2127399 through evaluation of laboratory tests, vital signs and electrocardiograms at various time points in the study
  • Evaluation of the pharmacokinetics of LY2127399 in patients through blood sample collections at various time points in the study.
Not Provided
Not Provided
 
A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Patients With Rheumatoid Arthritis
Phase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With Methotrexate

This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for patients with Rheumatoid Arthritis. Patients will receive three intravenous doses of LY2127399 or placebo. Patients will participate in 10 or more visits to the study site, over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: LY2127399
    30 mg, 60 mg or 160 mg, IV (in the vein)in weeks 0, 3 and 6. Treatment duration: 6 weeks.
  • Drug: Placebo
    IV (in vein) in weeks 0,3 and 6. Treatment duration: 6 weeks.
  • Experimental: A
    Intervention: Drug: LY2127399
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Genovese MC, Bojin S, Biagini IM, Mociran E, Cristei D, Mirea G, Georgescu L, Sloan-Lancaster J. Tabalumab in rheumatoid arthritis patients with an inadequate response to methotrexate and naive to biologic therapy: a phase II, randomized, placebo-controlled trial. Arthritis Rheum. 2013 Apr;65(4):880-9. doi: 10.1002/art.37820.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female between the ages of 18 and 75 years
  • Have given written informed consent approval
  • 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

Exclusion Criteria:

  • Use of excluded medications (reviewed by study doctor)
  • Surgical treatment of a joint that is to be assessed in the study
  • Are unable to ambulate; that is, confined to bed or wheelchair bound
  • 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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00308282
11055, H9B-MC-BCDF
Not Provided
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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2008

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