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NCT00206648: ABOVE
A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex
Phase 4 trial testing Betaferon/Betaseron in Multiple Sclerosis, Relapsing-Remitting in 271 participants. Completed in 1 October 2005.
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 271 |
| Start date | 1 March 2003 |
| Estimated completion | 1 October 2005 |
| Sites | 53 locations across United States, Canada |
Drugs / interventions tested
- Betaferon/Betaseron — full drug profile →
- Betaferon/Betaseron — full drug profile →
Conditions studied
- Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →
Sponsor
Bayer — full company profile →
Who can join
Adults 18 to 60, any sex, with Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Time to onset of first relapse
Time frame: Time to onset of first relapse
Sponsor's own description
The purpose of this study is to determine the difference in preventing a relapse between Betaseron and Avonex. Patients with RRMS currently treated with Avonex will be randomized into 2 equal-size arms; one arm will continue on the standard dose of Avonex; one arm will be converted to Betaseron standard dose.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.
Tramacere I, Virgili G, Perduca V, Lucenteforte E, et al · · 2023 · cited 10× · PMID 38032059 · DOI 10.1002/14651858.cd012186.pub2
Verify or expand the search:
- PubMed search for NCT00206648
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Bayer trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00206648 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 30 December 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00206648.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing