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A Study of Patients With Relapsing Remitting Multiple Sclerosis
This study is currently recruiting participants.
Study NCT00882999   Information provided by Eli Lilly and Company
First Received: April 16, 2009   Last Updated: October 5, 2009   History of Changes

April 16, 2009
October 5, 2009
April 2009
March 2011   (final data collection date for primary outcome measure)
Reduction in cumulative total gadolinium (Gd)-enhancing MRI lesions. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00882999 on ClinicalTrials.gov Archive Site
  • Total number of Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
  • Total number of new or newly enlarging T2-weighted MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
  • Time to first relapse. [ Time Frame: Weeks 24, 48 and period in between. ] [ Designated as safety issue: No ]
  • Proportion of relapse-free subjects. [ Time Frame: Weeks 24, 48 and period in between. ] [ Designated as safety issue: No ]
  • Proportion of subjects with anti-LY2127399 antibodies. [ Time Frame: 24, 48, and 72 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics of selected peripheral B cell subsets. [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
  • Serum pharmacokinetics (AUC). [ Time Frame: 42 weeks ] [ Designated as safety issue: No ]
  • Expanded Disability Status Scale (EDSS). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
  • Multiple Sclerosis Functional Composite Scale (MSFC). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) of Wellbeing. [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
  • 16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16). [ Time Frame: 12, 24, and 48 weeks ] [ Designated as safety issue: No ]
  • Total number of new Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
  • Total volume of T2-weighted MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ] [ Designated as safety issue: No ]
  • Annualized relapse rate. [ Time Frame: Weeks 24 and 48. ] [ Designated as safety issue: No ]
Same as current
 
A Study of Patients With Relapsing Remitting Multiple Sclerosis
Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Relapsing-Remitting Multiple Sclerosis
  • Drug: LY2127399
  • Drug: Placebo
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
245
September 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 through 64 years of age diagnosed with relapsing-remitting multiple sclerosis (RRMS), who can walk without aid or rest for at least 200 meters (approximately 1/10 of a mile).
  • Women who can become pregnant must use birth control.

Exclusion Criteria:

  • Have had a live vaccination within 12 weeks before randomization, or intend to have a live vaccination during the course of the study.
  • Have had had recent surgery or are scheduled to have surgery during the study.
  • Are immunocompromised or have evidence of active infection (such as hepatitis, tuberculosis or, human immunodeficiency virus [HIV]).
  • Have been on certain drugs that are being studied for RRMS or have recently received prescription drugs to treat RRMS.
  • Have had a recent serious infection.
  • Have serious or uncontrolled illnesses other than RRMS.
  • Have clinically significant blood test values.
  • Have multiple or severe drug allergies.
  • Have contraindications for magnetic resonance imaging (MRI; "scanning") or claustrophobia (fear of an enclosed space) that cannot be managed.
Both
18 Years to 64 Years
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Israel,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Switzerland,   Ukraine
 
NCT00882999
Chief Medical Officer, Eli Lilly
12778, H9B-MC-BCDJ
Eli Lilly and Company
 
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
October 2009

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