Phase 2
Completed N=249
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
Source: ClinicalTrials.gov NCT00207727 ↗Enrolled (actual)
249
Serious AEs
2.8%
Results posted
Dec 2009
Primary outcomePrimary: The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23. — 1.20; 1.00; 2.00; 2.40 Lesions — p=0.00
Summary
The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23. |
1.20; 1.00; 2.00; 2.40; 2.00 | 0.00 sig |
| SECONDARY Relapses of Multiple Sclerosis (MS) Through Week 23 |
0.00; 0.00; 0.00; 0.00; 0.00 | 0.892 |
| SECONDARY Change From Baseline in Expanded Disability Status Scale (EDSS) |
0.00; 0.00; 0.00; 0.00; 0.00 | 0.720 |
Eligibility Criteria
Inclusion Criteria
- Have a definite diagnosis of Relapsing remitting Multiple Sclerosis
- Have a history of at least 1 of the following:a. A minimum of 2 relapses of MS within the previous 2 years but not within the 1-month period prior to screening. b. A relapse of MS within the previous 6 months but not within the 1-monthperiod prior to screening
Exclusion Criteria
- Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous)
- Have significant bulbar involvement of MS or other neurologic deficits
- Have a decubitus ulcer
- Have received immunomodulatory therapies within 3 months of screening
Data sourced from ClinicalTrials.gov (NCT00207727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.