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NCT02076841: SFERA
Tolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)
trial testing interferon beta-1a in Relapsing-Remitting Multiple Sclerosis in 40 participants. Completed in 1 October 2016.
1 February 2016
Quick facts
| Lead sponsor | Biogen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 1 July 2013 |
| Primary completion | 1 February 2016 |
| Estimated completion | 1 October 2016 |
| Sites | 11 locations across Czechia, Switzerland |
Drugs / interventions tested
- interferon beta-1a (INTERFERON BETA-1A) — full drug profile →
Conditions studied
- Relapsing-Remitting Multiple Sclerosis — all drugs for Relapsing-Remitting Multiple Sclerosis →
- Clinical Isolated Syndrome (CIS) — all drugs for Clinical Isolated Syndrome (CIS) →
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Biogen — full company profile →
Who can join
18 and older, any sex, with Relapsing-Remitting Multiple Sclerosis or Clinical Isolated Syndrome (CIS). 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.
-
Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100
Time frame: Up to 4 months
Sponsor's own description
To evaluate treatment tolerability, adherence and quality of life (QoL) over 1 year in MS (Multiple Sclerosis) participants who have been switched - due to persistent tolerability issues, particularly injection problems - from a subcutaneous injectable disease-modifying treatment (DMT) given several times a week (Rebif, Betaferon or Copaxone) to once weekly Avonex 30 μg given intra-muscularly. Avonex will be applied by the injection device Avonex Pen.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02076841
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of interferon beta-1a
Trials testing the same drug.
- NCT03177083 — Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy · Phase 4 · completed
Other recruiting trials for Relapsing-Remitting Multiple Sclerosis
Currently open trials in the same condition.
- NCT05123703 — A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Re · Phase 3 · active not recruiting
- NCT05090371 — A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation · Phase 4 · active not recruiting
- NCT04530318 — Dendritic Cells Therapy Combined With Immunomodulatory Treatment in Multiple Sclerosis · Phase 2 · active not recruiting
Other Biogen trials
Trials by the same sponsor.
- NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
- NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
- NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
- NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
- NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting
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 NCT02076841 (US National Library of Medicine, public domain)
- 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: 26 January 2017
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/NCT02076841.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing