Glatiramer Acetate (Copaxone®) Study to Follow Participants From the First Original Study for Safety and Effectiveness

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Relapsing-Remitting Multiple Sclerosis

Treatments: Drug: Glatiramer acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00203021

01-9004 (Other Identifier)

GA-9004

Details and patient eligibility

About

This open-label extension study will evaluate the long-term safety of glatiramer acetate and its effect on the neurologic course of participants with relapsing-remitting multiple sclerosis (RRMS). Participants have scheduled visits every 3 months to assess glatiramer acetate safety and their Multiple Sclerosis (MS) status.

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have participated (been randomized) in the Copaxone double-blind placebo-controlled study 01-9001 and/or the double-placebo-controlled extension study 01-9001E.
• Participants could be male or female. Women of childbearing potential must have practiced an acceptable method of birth control.
• Participants must have completed the scheduled termination visit for Amendment 12 (Month 264).
• Participants must have signed an approved informed consent form (ICF) prior to continuing in the study extension or at the first visit in the extension (Month 264 which corresponds to the termination visit of Amendment 12).
• Participants must have been psychologically and physically stable to participate in the trial as judged by the investigator.
• All participants enrolled in this extension study were required to have the following study-specific baseline characteristics prior to entry to Study 01-9001: a diagnosis of RRMS as defined by Poser et al 1983, at least 2 clearly identified relapses and remissions in the 2-year period prior to study entry, ambulatory with a Kurtzke EDSS score of 0 to 5.0 inclusive, and a stable neurologic state for at least 30 days prior to study entry.

Exclusion criteria

• Pregnancy or lactation.
• Medical or psychiatric conditions that affect the participant's ability to give informed consent or complete the study.
• Inability to self-administer subcutaneous medication or lack of another responsible individual to administer the study preparation daily.
• Use of approved MS therapies including interferons, experimental MS therapies, or previous immunosuppressive therapy with cytotoxic chemotherapy (azathioprine, cyclophosphamide, or cyclosporine).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

208 participants in 2 patient groups

Glatiramer Acetate: Delayed Start

Experimental group

Description:

Participants who were originally randomized to the placebo group in the 01-9001 and/or the 01-9001E studies received glatiramer acetate 20 milligrams (mg) subcutaneous (SC) injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg three times weekly (TIW). The treatment continued for up to 288 months.

Treatment:

Drug: Glatiramer acetate

Glatiramer Acetate: Early Start

Experimental group

Description:

Participants who were originally randomized to the glatiramer acetate 20 mg group in the 01-9001 and/or the 01-9001E studies continued to receive glatiramer acetate 20 mg SC injection daily at the start of this study. After 18 July 2014 (protocol amendment 12), participants were offered the opportunity to continue treatment with glatiramer acetate 20 mg daily or switch to glatiramer acetate 40 mg TIW. The treatment continued for up to 288 months.

Treatment:

Drug: Glatiramer acetate