Trial · NCT01920477
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy | Baseline up to approximately 60 weeks | Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintenance of a dose \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks and maintenance of the status until Week 60. |
| Primary | Duration of Remission on Minimal Steroid Therapy | Baseline up to approximately 60 weeks | Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day up to Week 60 was assessed. |
| Secondary | Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60 | Week 60 | Percentage of subjects who achieved absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day for \> or = 8 weeks at Week 60 was assessed. Time to remission was not estimable. |
| Secondary | Time to Remission While on Minimal Steroid Therapy by Week 60. | Baseline up to approximately 60 weeks | Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to \<=10 mg/day and maintained dose at \<=10 mg/day with no new or nonhealing lesions for \>=8 weeks by Week 60 was assessed |
| Secondary | Percentage of Subjects Achieving Remission While Off Steroid Therapy by Week 60 | Baseline up to approximately 60 weeks | Percentage of subjects with initial reduction of all steroids for \>=8 weeks with an absence of new or nonhealing (established) lesions by Week 60 were to be assessed. All subjects remained on prednisone/prednisolone so this endpoint could not be analyzed.Time to remission off steroid therapy also could not be analyzed |
| Secondary | Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60. | Baseline up to approximately 60 weeks | Number of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60. |
| Secondary | Time to Initial Flare/Relapse by Week 60 | Baseline up to approximately 60 weeks | Time from randomization to the time of appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed |
| Secondary | Percentage of Participants With no Flare/Relapse by Week 60 | Baseline up to approximately 60 weeks | Percentage of participants achieving absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of \<=10 mg/day and did not subsequently have a appearance of \>=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed |
| Secondary | Plasma Trough Concentrations of Ofatumumab | 4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeks | Only plasma (trough) concentrations of ofatumumab were presented |
| Secondary | Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A | Baseline up to approximately 60 weeks | Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response |
| Secondary | Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G | Baseline up to approximately 60 weeks | Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response |
| Secondary | Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M | Baseline up to approximately 60 weeks | Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response |
| Secondary | Largest Mean Decrease From Baseline for Immunoglobulin A, G and M | Baseline up to approximately 60 weeks | Immunoglobulins A, G and M were assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response |
| Secondary | Change From Baseline for CD19+ B Cell Count | Baseline up to approximately 60 weeks | CD19+ B cell count will be performed using Flow Cytometry |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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