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NCT00784836
A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis
Phase 3 trial testing BG9418 (interferon beta 1-a) in Multiple Sclerosis in 3 participants. Terminated before completion.
1 February 2009
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 1 October 2008 |
| Primary completion | 1 February 2009 |
| Estimated completion | 1 February 2009 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- BG9418 (interferon beta 1-a) — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Biogen — full company profile →
Who can join
Adults 18 to 60, any sex, with Multiple Sclerosis. 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.
-
Number of Participants Who Developed Neutralizing Antibodies (NAbs) to Interferon-beta (IFN-beta)
Time frame: assessed every 3 months up to 18 months
The presence of antibodies to IFN-beta in human serum, determined using a tiered approach involving a screening Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect binding antibodies (BAbs). Positive samples characterized and titrated in a cell-based neutralizing antibody (NAb) assay.
Sponsor's own description
The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pharmacological Approaches to Delaying Disability Progression in Patients with Multiple Sclerosis.
Wiendl H, Meuth SG. · · 2015 · cited 24× · PMID 26033077 · DOI 10.1007/s40265-015-0411-0
Verify or expand the search:
- PubMed search for NCT00784836
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00784836 (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 Biogen
- Last refreshed: 7 April 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/NCT00784836.
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