Trial Outcomes & Findings for Rebif® Versus Copaxone® in the Treatment of Relapsing Remitting Multiple Sclerosis (NCT NCT00078338)

Last Updated: 2018-06-27

Results Overview

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 increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

764 participants

Primary outcome timeframe

Baseline up to 96 weeks

Results posted on

2018-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Rebif® Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).	Copaxone® Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Overall Study STARTED	386	378
Overall Study Safety Population	381	375
Overall Study COMPLETED	301	324
Overall Study NOT COMPLETED	85	54

Reasons for withdrawal

Reasons for withdrawal
Measure	Rebif® Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).	Copaxone® Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Overall Study Adverse Event	31	24
Overall Study Lost to Follow-up	17	2
Overall Study Protocol Violation	2	2
Overall Study Disease Progression	4	7
Overall Study Other	28	16
Overall Study Subjects randomized, but not treated	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rebif® n=386 Participants Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).	Copaxone® n=378 Participants Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).	Total n=764 Participants Total of all reporting groups
Age, Customized Less than 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18 years to 64 years	386 Participants n=5 Participants	378 Participants n=7 Participants	764 Participants n=5 Participants
Age, Customized Greater than 64 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	267 Participants n=5 Participants	272 Participants n=7 Participants	539 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	106 Participants n=7 Participants	225 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 96 weeks

Population: The ITT population consisted of all subjects who were randomized.

Outcome measures

Outcome measures
Measure	Rebif® n=386 Participants Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).	Copaxone® n=378 Participants Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
Time to First Relapse 25th Percentile	332.0 days Standard Deviation 10.9	290.0 days Standard Deviation 9.5
Time to First Relapse 30th Percentile	495.0 days Standard Deviation 16.3	432.0 days Standard Deviation 14.2

Adverse Events

Rebif®

Serious events: 29 serious events

Other events: 346 other events

Deaths: 0 deaths

Copaxone®

Serious events: 27 serious events

Other events: 320 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Merck KGaA Communication Center

Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Rebif® n=381 participants at risk Subjects were administered with Rebif® (Recombinant interferon beta-1a) as subcutaneous (SC) injection at a dose of 44 microgram (mcg) three times weekly (tiw).	Copaxone® n=375 participants at risk Subjects were administered with Copaxone® (Glatiramer acetate) as subcutaneous (SC) injection at a dose of 20 milligram (mg) once daily (qd).
General disorders Injection site erythema	31.8% 121/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	30.4% 114/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Influenza like illness	31.2% 119/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	1.3% 5/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Nervous system disorders Headache	19.4% 74/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	9.3% 35/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Injection site pain	12.3% 47/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	14.1% 53/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Injection site pruritus	2.1% 8/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	20.0% 75/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Infections and infestations Nasopharyngitis	8.9% 34/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	11.7% 44/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Injection site bruising	8.7% 33/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	10.1% 38/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Gastrointestinal disorders Nausea	6.6% 25/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	7.5% 28/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Psychiatric disorders Depression	7.9% 30/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	5.9% 22/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Musculoskeletal and connective tissue disorders Back pain	6.6% 25/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	6.9% 26/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Infections and infestations Sinusitis	4.7% 18/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	7.7% 29/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Injection site swelling	1.0% 4/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	11.2% 42/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Infections and infestations Upper respiratory tract infection	3.9% 15/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	7.2% 27/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Infections and infestations Influenza	4.7% 18/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	5.9% 22/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 18/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	5.9% 22/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Infections and infestations Urinary tract infection	4.5% 17/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	5.3% 20/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Pyrexia	6.0% 23/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	3.7% 14/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Injection site induration	2.4% 9/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	6.7% 25/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Psychiatric disorders Anxiety	5.5% 21/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	2.9% 11/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Musculoskeletal and connective tissue disorders Myalgia	5.8% 22/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	2.1% 8/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 4/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	5.9% 22/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
Investigations Alanine aminotransferase increased	5.5% 21/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	1.3% 5/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.
General disorders Adverse drug reaction	0.00% 0/381 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.	5.1% 19/375 The Safety population consisted of all subjects who received at least 1 dose of study treatment and had follow-up safety data.