Trial Outcomes & Findings for Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI (NCT NCT00176592)

NCT ID: NCT00176592

Last Updated: 2021-11-16

Results Overview

Results are per patient mean number of lesions per scan. Results are per patient mean number of lesions per elapsed month. Contrasts types are: IFN 1b interferon beta 1b and GA glatiramer acetate.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 75 participants
• Primary outcome timeframe: up to 2 years
• Results posted on: 2021-11-16

Participant Flow

Participant milestones

Measure	Betaseron Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day	Copaxone 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)
Overall Study STARTED	36	39
Overall Study Followed for 1 Year	35	35
Overall Study Followed for 2 Years	29	35
Overall Study COMPLETED	36	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI

Baseline characteristics by cohort

Measure	Betaseron n=36 Participants Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day	Copaxone n=39 Participants 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36 Years n=5 Participants	36 Years n=7 Participants	36 Years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	39 participants n=7 Participants	75 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 2 years

Population: Randomization was stratified by the presence or absence of enhancement. Analysis was intention to treat.

Results are per patient mean number of lesions per scan. Results are per patient mean number of lesions per elapsed month. Contrasts types are: IFN 1b interferon beta 1b and GA glatiramer acetate.

Outcome measures

Measure	Betaseron n=1688 Combined Active Lesions Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day	Copaxone n=1053 Combined Active Lesions 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)
The Primary Outcome Measure is the Number of "Combined Active Lesions" (CAL) by Monthly MRI at the Conclusion of the Study.	0.63 Average number of lesions per scan Standard Deviation 2.76	0.58 Average number of lesions per scan Standard Deviation 2.46

SECONDARY outcome

Timeframe: up to 2 years

The first part of the secondary outcome measure is the total number of enhancing lesions per patient per treatment arm.

The second part of the secondary outcome is the total number of new enhancing lesions per patient per treatment arm.

Outcome measures

Measure	Betaseron n=1531 Enhancing Lesion Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day	Copaxone n=973 Enhancing Lesion 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)
The Number of Enhancing Lesions.	878 New Enhancing Lesion	626 New Enhancing Lesion

SECONDARY outcome

Timeframe: 1 year

The 1 year MRI results were used to determine the quantity of disease free patients per contrast type.

Outcome measures

Measure	Betaseron n=36 Participants Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day	Copaxone n=39 Participants 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)
The Number of MRI Disease Free Patients. The number of relapse-free patients at the completion of the study.	19 participants	28 participants
The Number of MRI Disease Free Patients. Free of combined active lesions, namely the combination of enhancing lesions plus new T2 lesions.	7 participants	10 participants

Adverse Events

Betaseron

Serious events: 7 serious events

Other events: 2 other events

Deaths: 0 deaths

Copaxone

Serious events: 7 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Betaseron n=36 participants at risk Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day	Copaxone n=39 participants at risk 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)
Pregnancy, puerperium and perinatal conditions Pregnancy	5.6% 2/36 • Number of events 2 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	2.6% 1/39 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Respiratory, thoracic and mediastinal disorders Malignant Nodule in Lung	0.00% 0/36 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	2.6% 1/39 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Gastrointestinal disorders Gastroenteritis	2.8% 1/36 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	0.00% 0/39 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Ear and labyrinth disorders Loss of Hearing	2.8% 1/36 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	0.00% 0/39 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Injury, poisoning and procedural complications Pain near IV Site	0.00% 0/36 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	2.6% 1/39 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Nervous system disorders Myelitis	0.00% 0/36 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	2.6% 1/39 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Blood and lymphatic system disorders Venous Thromboembolism	0.00% 0/36 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	2.6% 1/39 • Number of events 2 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Ear and labyrinth disorders Balance Impairment	0.00% 0/36 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	2.6% 1/39 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Vascular disorders Aneurysm	2.8% 1/36 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	0.00% 0/39 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Endocrine disorders Pancreatitis	2.8% 1/36 • Number of events 3 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	0.00% 0/39 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
Gastrointestinal disorders Gastritis	0.00% 0/36 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	2.6% 1/39 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
General disorders Pain	2.8% 1/36 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	0.00% 0/39 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.

Other adverse events

Measure	Betaseron n=36 participants at risk Betaseron 250 micrograms SQ every other day Betaseron: Betaseron 250 micrograms injected SQ every other day	Copaxone n=39 participants at risk 20 mg daily SQ Copaxone: Copaxone 20 mg injected SQ every day (glatiramer acetate)
General disorders Pain/Burning at Injection Site	2.8% 1/36 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	5.1% 2/39 • Number of events 2 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
General disorders Headache/Dizziness	0.00% 0/36 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	5.1% 2/39 • Number of events 2 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.
General disorders Pain	2.8% 1/36 • Number of events 1 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.	7.7% 3/39 • Number of events 4 • Adverse events in the form of symptoms were gathered over the duration of the study (24 months). Adverse events were recorded spontaneously and upon questioning by nurse at MRI for the hour of the MRI. Additional events were recorded at follow up visit within three months of MRI. Additional lab results were studied at follow up visit within three months of MRI. Finally, lab results and clinical adverse events were studied at three interim analyses by data monitoring committee.

Additional Information

Stuart Cook, MD

Rutgers New Jersey Medical School

Phone: 973-972-2550

Email: cooksd@njms.rutgers.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place