Phase 2
N=53
Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01569451 ↗Enrolled (actual)
53
Serious AEs
10.9%
Results posted
Jun 2018
Primary outcome: Primary: Number of Disease-free Patients — 5; 12 participants — p=0.0493
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Drug); Glatiramer Acetate (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Disease-free Patients |
5; 12 | 0.0493 sig |
| SECONDARY Time to Treatment Failure |
11.29; 23.32 | 0.0268 sig |
| SECONDARY Number of Subjects That Fail Treatment |
18; 10 | 0.0189 sig |
| SECONDARY Number of Relapse-free Subjects |
17; 21 | 0.3167 |
| SECONDARY Number of Patients Treated for Relapse With Corticosteroid |
9; 4 | 0.0940 |
| SECONDARY Number of Subjects Who Experience Multiple Relapses |
3; 1 | 0.3507 |
| SECONDARY Number of Patients That Develop Sustained Accumulation of Disability |
3; 4 | 1.0000 |
| SECONDARY Change From Baseline to 24 Months on the Multiple Sclerosis Functional Composite (MSFC) Z-score |
0.5226; 0.2630 | 0.4904 |
| SECONDARY Percentage of Subjects Worsening One Point or More on the Patient Determined Disease Steps (PDDS) Questionnaire |
6; 9 | 0.4073 |
| SECONDARY Change in Mean Score on Performance Scales (Baseline to 24 Months) |
0.1466; 0.3477 | 0.8677 |
Summary
The purpose of this study is (1) to determine if rituximab induction therapy followed by glatiramer acetate (GA) is substantially superior to placebo rituximab induction followed by GA for the treatment of clinically isolated syndrome (CIS) or relapsing forms of multiple sclerosis (RMS).
Eligibility Criteria
Inclusion Criteria
- 18 through 55 years of age
- Patients with CIS demonstrating one unifocal neurological event AND at least 2 T2-weighted brain lesions measuring a minimum of 6mm in diameter by MRI analysis; or a definite diagnosis of RMS, as defined by the 2005 revised McDonald criteria(1, 2), and have had at least one clinically defined relapse within the past year OR one GEL on an MRI within the past year
- Women of child-bearing potential must agree to practice an acceptable method of birth control
- No evidence of progressive multifocal leukoencephalopathy (PML) or primary central nervous system (PCNS) lymphoma
- Neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization
- Subject must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with local regulatory requirements.
Exclusion Criteria
- ≥ 15 GELs on baseline MRI
- Treatment with interferon β, natalizumab, or fingolimod within three months of randomization
- Treatment with mitoxantrone, cyclophosphamide, or any other chemotherapeutic agent for MS or malignancy within 12 months of randomization
- Attenuated live virus vaccination within 4 weeks of randomization
- Positive urine and serum pregnancy test at screening or baseline visit
- Any prior treatment with alemtuzumab or cladribine
- Unable to tolerate GA
- History of cardiac arrhythmias, angina or any other significant cardiac abnormalities
- History of clinically significant chronic disease of the immune system or a known immunodeficiency syndrome (HIV) other than MS
- White Blood Cell count of less than 2.5*10^9/L or lymphocyte count below 0.4*10^9/L
- Positive for any evidence of past, or current, hepatitis B and/or C infection
- History or presence of malignancy (except basal cell carcinoma)
- Clinically significant alcohol or drug abuse within past two years
- Any medical, psychiatric or other condition that could result in a subject not being able to give fully informed consent, or to comply with the protocol requirements
- Inability to undergo MRI scans or history of hypersensitivity to gadolinium- diethylenetriamine penta-acetic acid (DTPA)
- Participation in any clinical study evaluating another investigational drug or therapy within three months prior to randomization
- Any other condition that, in the Investigator's opinion, makes the subject unsuitable for participation in the study
Data sourced from ClinicalTrials.gov (NCT01569451). 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.