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NCT00436826 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 172
- Enrollment target
NCT00436826: Completed Phase 2 study, sponsored by EMD Serono Research & Development Institute.
NCT00436826 is a Phase 2 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 172 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00436826, a Phase 2 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 172 participants
- Enrollment target
Study Summary
The goal of this study was to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the treatment of multiple sclerosis (MS). This study randomized around 200 participants from approximately 50 sites located world-wide, who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior to Screening, irrespective of disability progression. Secondary progressive multiple sclerosis (SPMS) participants, who were still experiencing relapses, and participants who have received disease modifying drugs (DMDs), other than IFN-beta therapy, during their MS treatment history, but were currently on IFN-beta therapy and have experienced active MS symptoms (at least 1 relapse) during the 48 weeks prior to Screening, were enrolled. Participants were randomized in a 2:1 fashion to receive up to 4 cycles of oral cladribine or matching placebo in combination with IFN-beta therapy. Participants who completed the double-blind portion of the study were invited to participate in an open-label extension phase of matching study design.
Primary Outcome
Percentage of participants with Grade 3 or 4 CTCAE v 4.0 toxicity on the following hematology and liver function parameters were reported: lymphocytes, cluster of differentiation 4 (CD4) cell, neutrophils, white blood cells, hemoglobin, Alanine transaminase (ALT), Aspartate transaminase (AST), Platelets and Bilirubin. According to CTCAE v 4.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.
Interventions
- DRUG Placebo
- DRUG Cladribine
- DRUG Interferon-beta (IFN-beta)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2006-11-30 |
| Est. Completion | 2012-03-31 |
| Phase | Phase 2 |
What the finished NCT00436826 record still lists
NCT00436826 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00436826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00436826 about?
NCT00436826 is a clinical study titled "A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)". The goal of this study was to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the treatment of multiple sclerosis (MS). This study randomized around 200 participants from approximately 50 sites located worl...
What is the current status of trial NCT00436826?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2006-11-30. Estimated completion is 2012-03-31.
What interventions are being tested in trial NCT00436826?
The interventions under investigation include: Placebo (DRUG), Cladribine (DRUG), Interferon-beta (IFN-beta) (DRUG).
Who is sponsoring clinical trial NCT00436826?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00436826's enrollment target sits among peer trials
172 397th of 2000 higher than 1,603 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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