Analysis of the antibody level against interferon beta before and after increase of dose in MS therapy - Interferon beta dose and antibody

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001008-37-SE

Enrollment

100

Registered

2005-03-21

Start date

2005-11-01

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis

Interventions

Trade Name: Rebif® Product Name: Rebif® Product Code: Not applicable Pharmaceutical Form: Solution for injection INN or Proposed INN: Interferon beta-1a Current Sponsor code: Not applicable Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Multiple sclerosis patients aged 18-65 years treated by Rebif 22 microgram/dose for more than 1 year. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Insufficient patient compliance.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether increase from 22 microgram to 44 microgram per dose interferon beta-1a three times a week will reduce the level of binding and neutralizing antibodies to interferon beta by high dose tolerance or other mechanisms.;Secondary Objective: To evaluate the severity of multiple sclerosis in relation to the dose and the level of binding and neutralizing antibodies to interferon beta by clinical score (EDSS and relapse frequency) and two potential activity markers in blood (MRP8/14 and iNOs);Primary end point(s): Evaluation of the level of binding and neutralizing antibodies to interferin beta before and after increase of the dose from 22 to 44 micrograms/dose, with two years of follow-up after the change of dose	—

Measure

Time frame

Main Objective: To determine whether increase from 22 microgram to 44 microgram per dose interferon beta-1a three times a week will reduce the level of binding and neutralizing antibodies to interferon beta by high dose tolerance or other mechanisms.;Secondary Objective: To evaluate the severity of multiple sclerosis in relation to the dose and the level of binding and neutralizing antibodies to interferon beta by clinical score (EDSS and relapse frequency) and two potential activity markers in blood (MRP8/14 and iNOs);Primary end point(s): Evaluation of the level of binding and neutralizing antibodies to interferin beta before and after increase of the dose from 22 to 44 micrograms/dose, with two years of follow-up after the change of dose

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026