A Study of Patients With Relapsing Remitting Multiple Sclerosis


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: April 16, 2009)		Reduction in cumulative total gadolinium (Gd)-enhancing MRI lesions. [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00882999 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: April 16, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEA Study of Patients With Relapsing Remitting Multiple Sclerosis
Official Title  ICMJEMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis
Brief Summary

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

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJERelapsing-Remitting Multiple Sclerosis
Intervention  ICMJE
  • Drug: LY2127399
    Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
  • Drug: Placebo
    Injection: Every 4 weeks in the placebo arm for 24 weeks. Every 4 weeks in the LY arms for 24 weeks (except week 12 and week 24).
Study Arms / Comparison Groups
  • Placebo: Placebo Comparator
    Intervention: Drug: Placebo
  • 4 mg LY2127399 / 4 weeks: Experimental
    Intervention: Drug: LY2127399
  • 40 mg LY2127399 / 4 weeks: Experimental
    Intervention: Drug: LY2127399
  • 120 mg LY2127399 / 4 weeks: Experimental
    Intervention: Drug: LY2127399
  • 4 mg LY2127399 / 12 weeks: Experimental
    Interventions:
    • Drug: LY2127399
    • Drug: Placebo
  • 120 mg LY2127399 / 12 weeks: Experimental
    Interventions:
    • Drug: LY2127399
    • Drug: Placebo
  • 12 mg LY2127399 / 4 weeks: Experimental
    Intervention: Drug: LY2127399

Recruitment Information

Estimated Enrollment  ICMJE245
Estimated Completion DateSeptember 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years to 64 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEUnited States,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Israel,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Switzerland,   Ukraine

Administrative Information

NCT ID  ICMJENCT00882999
Responsible PartyChief Medical Officer, Eli Lilly
Study ID Numbers  ICMJE12778, H9B-MC-BCDJ
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
Investigators  ICMJE
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, ESTEli Lilly and Company
Information Provided ByEli Lilly and Company