ong-term Extension Study to Evaluate the Safety and Efficacy of Daclizumab High Yield Process

Phase 2

Completed

• Conditions: Health Condition 1: null- Relapsing-Remitting Multiple Sclerosis (RRMS)

• Registration Number: CTRI/2012/05/002705
• Lead Sponsor: Biogen Idec

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

1.Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.

2.Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator.

3.Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.

Exclusion Criteria

1.Subjects with any significant change in their medical status from the previous study that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjectâ??s participation in the 205MS201 or 205MS202 studies. The Investigator must re review the subjectâ??s medical fitness for participation and must consider any diseases that would preclude treatment.

2.Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE.

3.Current enrollment in any investigational drug study other than Study 205MS202.

4.Ongoing treatment with any approved or experimental disease-modifying treatment for MS.

5.Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subjectâ??s ability to comply with the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified