Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Celgene
The trial is an open label extension study. Eligible patients from the RPC01-201, RPC01-301, and RPC01-1001 trials diagnosed with relapsing Multiple Sclerosis (RMS) will be enrolled to receive study drug until the end of the trial or until the Sponsor discontinues the development program.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eligibility Criteria:
To be eligible to participate in this trial, patients must meet all of the following criteria:
1. Completed one of the parent trials
2. Does not have a condition that would require withdrawal from one of the parent trials
3. Has no conditions requiring treatment with a prohibited concomitant medication
4. Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:
At Baseline (Day 1)
* CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
5. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
6. Female patients of childbearing potential:
Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
Acceptable methods of birth control in this study are the following:
Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
Placement of an intrauterine device (IUD)
Placement of an intrauterine hormone-releasing system (IUS)
