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A Study of Patients With Relapsing Remitting Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00882999
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Drug: LY2127399 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis
Study Start Date : April 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo 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).
Experimental: 4 mg LY2127399 / 4 weeks Drug: LY2127399
Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
Experimental: 40 mg LY2127399 / 4 weeks Drug: LY2127399
Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
Experimental: 120 mg LY2127399 / 4 weeks Drug: LY2127399
Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.
Experimental: 4 mg LY2127399 / 12 weeks 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).
Experimental: 120 mg LY2127399 / 12 weeks 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).
Experimental: 12 mg LY2127399 / 4 weeks Drug: LY2127399
Injection: 6 doses, one every 4 weeks or every 12 weeks for 24 weeks.



Primary Outcome Measures :
  1. Reduction in cumulative total gadolinium (Gd)-enhancing MRI lesions. [ Time Frame: Baseline, 24 weeks ]

Secondary Outcome Measures :
  1. Total number of Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ]
  2. 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 ]
  3. Time to first relapse. [ Time Frame: Weeks 24, 48 and period in between. ]
  4. Proportion of relapse-free subjects. [ Time Frame: Weeks 24, 48 and period in between. ]
  5. Proportion of subjects with anti-LY2127399 antibodies. [ Time Frame: 24, 48, and 72 weeks ]
  6. Pharmacodynamics of selected peripheral B cell subsets. [ Time Frame: Week 72 ]
  7. Serum pharmacokinetics (AUC). [ Time Frame: 42 weeks ]
  8. Expanded Disability Status Scale (EDSS). [ Time Frame: 12, 24, and 48 weeks ]
  9. Multiple Sclerosis Functional Composite Scale (MSFC). [ Time Frame: 12, 24, and 48 weeks ]
  10. Visual Analog Scale (VAS) of Wellbeing. [ Time Frame: 12, 24, and 48 weeks ]
  11. Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). [ Time Frame: 12, 24, and 48 weeks ]
  12. 16-Item Quick Inventory for Depressive Symptomatology Self Report (QIDS-SR16). [ Time Frame: 12, 24, and 48 weeks ]
  13. Total number of new Gd-enhancing MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ]
  14. Total volume of T2-weighted MRI lesions. [ Time Frame: 4, 8, 12, 16, 20, 24, 30, 36, 42, and 48 weeks ]
  15. Annualized relapse rate. [ Time Frame: Weeks 24 and 48. ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882999


  Show 63 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00882999     History of Changes
Other Study ID Numbers: 12778
H9B-MC-BCDJ ( Other Identifier: Eli Lilly and Company )
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: July 2, 2012
Last Verified: June 2012

Keywords provided by Eli Lilly and Company:
Relapsing
Remitting
Multiple Sclerosis
Multiple
Sclerosis
MS
LY2127399

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs