Last reviewed · How we verify

NCT00078338

Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis

Completed Phase 4 Results posted Last updated 27 June 2018
What this trial tests

Phase 4 trial testing Rebif® in Relapsing-remitting Multiple Sclerosis in 764 participants. Completed in 28 November 2006.

Timeline
16 February 2004
Primary endpoint
28 November 2006
28 November 2006

Quick facts

Lead sponsorEMD Serono
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment764
Start date16 February 2004
Primary completion28 November 2006
Estimated completion28 November 2006
Sites80 locations across France, Italy, Netherlands, Russia, Austria, United Kingdom, Germany, Argentina

Drugs / interventions tested

Conditions studied

Sponsor

EMD Serono — full company profile →

Who can join

Adults 18 to 60, any sex, with Relapsing-remitting Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to First Relapse Primary · Baseline up to 96 weeks

Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an i

25th Percentile
GroupValue95% CI
Rebif®332.0± 10.9
Copaxone®290.0± 9.5
30th Percentile
GroupValue95% CI
Rebif®495.0± 16.3
Copaxone®432.0± 14.2

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rebif®
Serious: 29/381 (8%)
Deaths:
Copaxone®
Serious: 27/375 (7%)
Deaths:

Serious adverse events (64 terms)

ReactionSystemRebif®Copaxone®
IleusGastrointestinal disorders
Chest painGeneral disorders
Face oedemaGeneral disorders
DepressionPsychiatric disorders
LaryngospasmRespiratory, thoracic and mediastinal disorders
Acute sinusitisInfections and infestations
Upper respiratory tract infectionInfections and infestations
Urinary tract infectionInfections and infestations
BronchitisInfections and infestations
Chronic sinusitisInfections and infestations
Dental cariesInfections and infestations
DiverticulitisInfections and infestations
Otitis mediaInfections and infestations
Pneumonia bacterialInfections and infestations
Postoperative infectionInfections and infestations
Pyelonephritis acuteInfections and infestations
SinusitisInfections and infestations
Colitis ulcerativeGastrointestinal disorders
ConstipationGastrointestinal disorders
Diverticular perforationGastrointestinal disorders
Gastric ulcer perforationGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
Jejunal perforationGastrointestinal disorders
NauseaGastrointestinal disorders
PancreatitisGastrointestinal disorders
Other adverse events (23 terms — click to expand)

ReactionSystemRebif®Copaxone®
Injection site erythemaGeneral disorders
Influenza like illnessGeneral disorders
Injection site pruritusGeneral disorders
HeadacheNervous system disorders
Injection site painGeneral disorders
NasopharyngitisInfections and infestations
Injection site swellingGeneral disorders
Injection site bruisingGeneral disorders
DepressionPsychiatric disorders
SinusitisInfections and infestations
NauseaGastrointestinal disorders
Upper respiratory tract infectionInfections and infestations
Back painMusculoskeletal and connective tissue disorders
Injection site indurationGeneral disorders
PyrexiaGeneral disorders
InfluenzaInfections and infestations
ArthralgiaMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
DyspnoeaRespiratory, thoracic and mediastinal disorders
AnxietyPsychiatric disorders
Alanine aminotransferase increasedInvestigations
Urinary tract infectionInfections and infestations
Adverse drug reactionGeneral disorders

Most-reported serious reactions: Ileus, Chest pain, Face oedema, Depression, Laryngospasm, Acute sinusitis, Upper respiratory tract infection, Urinary tract infection.

Data from ClinicalTrials.gov NCT00078338 adverse events section.

Sponsor's own description

The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial.
    Mikol DD, Barkhof F, Chang P, Coyle PK, et al · · 2008 · cited 327× · PMID 18789766 · DOI 10.1016/s1474-4422(08)70200-x
  2. 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
  3. Brain volume loss in relapsing multiple sclerosis: indirect treatment comparisons of available disease-modifying therapies.
    Zivadinov R, Keenan AJ, Le HH, Ait-Tihyaty M, et al · · 2024 · cited 4× · PMID 39379875 · DOI 10.1186/s12883-024-03888-6

Verify or expand the search:

Other trials of Rebif®

Trials testing the same drug.

Other recruiting trials for Relapsing-remitting Multiple Sclerosis

Currently open trials in the same condition.

Other EMD Serono trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT00078338.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing