A Study of Patients With Relapsing Remitting Multiple Sclerosis
Tracking InformationStart Date ICMJE | April 2009 |
---|
Estimated Primary Completion Date | March 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 ICMJE | Same as current |
---|
Change History | Complete 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 ICMJE | Same as current |
---|
Descriptive InformationBrief Title ICMJE | A Study of Patients With Relapsing Remitting Multiple Sclerosis |
---|
Official Title ICMJE | Multiple 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 Phase | Phase II |
---|
Study Type ICMJE | Interventional |
---|
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
---|
Condition ICMJE | Relapsing-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 InformationEstimated Enrollment ICMJE | 245 |
---|
Estimated Completion Date | September 2011 |
---|
Estimated Primary Completion Date | March 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.
|
---|
Gender | Both |
---|
Ages | 18 Years to 64 Years |
---|
Accepts Healthy Volunteers | No |
---|
Contacts ICMJE | Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | | |
|
---|
Location Countries ICMJE | United States, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Israel, Poland, Romania, Russian Federation, Serbia, Slovakia, Switzerland, Ukraine |
---|
Administrative InformationNCT ID ICMJE | NCT00882999 |
---|
Responsible Party | Chief Medical Officer, Eli Lilly |
---|
Study ID Numbers ICMJE | 12778, H9B-MC-BCDJ |
---|
Study Sponsor ICMJE | Eli 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, EST | Eli Lilly and Company | |
|
---|
Information Provided By | Eli Lilly and Company |
---|
|