Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis: interferon beta-1b in relapsing MS, phase 2

An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS)

CompletedPhase 2Relapsing MSNCT00235989

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Interferon beta-1b
Interferon alpha/beta receptor agonist

Compared with

Interferon beta-1b
Interferon alpha/beta receptor agonist

Results by group

Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities

At End of Study Visit (week 234)

Group	Value	Number analysed
ET: IFNB-1b 250 mcg => 250 mcg	1 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	1 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	4 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	7 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	1 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	2 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	3 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	4 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	3 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	4 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	1 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	2 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	3 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	2 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	2 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	3 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	4 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	1 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	8 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	9 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	2 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	1 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	8 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	7 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	1 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	10 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	4 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	10 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	14 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	3 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	3 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	4 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	6 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	1 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	2 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	5 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	2 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	1 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	1 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	1 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	1 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20
ET: IFNB-1b 250 mcg => 250 mcg	0 participants	16
ET: IFNB-1b 500 mcg => 250 mcg	0 participants	6
ET: IFNB-1b 500 mcg => 500 mcg	0 participants	19
ET: IFNB-1b 250 mcg => 500 mcg	0 participants	20

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events
ET: IFNB-1b 250 mcg => 250 mcg	16	2 (12.5%)
ET: IFNB-1b 500 mcg => 250 mcg	6	0 (0.0%)
ET: IFNB-1b 500 mcg => 500 mcg	19	9 (47.4%)
ET: IFNB-1b 250 mcg => 500 mcg	20	4 (20.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities
At End of Study Visit (week 234)
PainImmune responseSafety

Other measures (1)

Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b
At End of Study Visit (week 234)
Immune response

Who could take part

Relapsing MS · 18 to 55

Show the full criteria

Inclusion criteria

* Signed and dated statement of informed consent * Completion of Protocol 307000A * Negative serum pregnancy test results * Agreement to adequate contraception, for female patients

Exclusion criteria

* Pregnancy or lactation * History of alcohol or drug abuse * Inability to administer subcutaneous injections either by self or by caregiver * Medical, psychiatric or other conditions that compromise the patient's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study * Any significant change in the patient's medical condition after enrollment in Study 307000A which would have lead to his/her exclusion from participation that study

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.

Loading reviews and guidelines…

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History

Started
Jun 2003
Main results due
Jan 2008
Finished
Jan 2008
Results posted
Jul 2009

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