Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00428584 · ClinicalTrials.gov registry record · Phase 3
RNF and Betaseron® Tolerability Study
A Phase 3 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 3
- Development phase
- 129
- Enrollment target
NCT00428584: Completed Phase 3 study, sponsored by EMD Serono.
NCT00428584 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 129 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00428584, a Phase 3 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 129 participants
- Enrollment target
Study Summary
To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.
Primary Outcome
Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection
Interventions
- DRUG New Formulation of rebif - human interferon beta-1a
- DRUG Interferon beta -1b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2006-12 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00428584 record still lists
NCT00428584 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which New Formulation of rebif - human interferon beta-1a is the first listed.
NCT00428584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00428584 about?
NCT00428584 is a clinical study titled "RNF and Betaseron® Tolerability Study". To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.
What is the current status of trial NCT00428584?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2006-12. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00428584?
The interventions under investigation include: New Formulation of rebif - human interferon beta-1a (DRUG), Interferon beta -1b (DRUG).
Who is sponsoring clinical trial NCT00428584?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00428584's enrollment target sits among peer trials
129 1597th of 2000 higher than 400 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03619850 · 129 participants · Phase 3
A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
- NCT05704361 · 129 participants · Phase 1
A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis
- NCT05919849 · 129 participants · Phase 1
Supporting Parents in Affirming Their Children's Experiences of Stigma
- NCT06313749 · 129 participants · NA
Safety and Effectiveness of Minimally Invasive Micro Sclerostomy (MIMS®) to Reduce Intraocular Pressure in Open-Angle Glaucoma Which is Not Controlled Despite Polypharmacy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia