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A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis

NCT02576717

CompletedPhase 3

Sponsor: Celgene

Conditions: Multiple Sclerosis

Interventions: RPC1063

Countries: United States, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Estonia, Georgia

The purpose of the trial is to determine the safety and efficacy of RPC1063 in patients with relapsing multiple sclerosis.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
   * Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
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)
* Bilateral tubal occlusion
* Vasectomised partner
* Sexual abstinence.

Exclusion Criteria:
Locations (175)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Berkeley, California, United States
  • Fresno, California, United States
  • Long Beach, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • Maitland, Florida, United States
  • Port Charlotte, Florida, United States
  • Sunrise, Florida, United States
  • Tampa, Florida, United States
  • Golden Valley, Minnesota, United States
  • Las Vegas, Nevada, United States
  • Raleigh, North Carolina, United States
  • Westerville, Ohio, United States
  • Knoxville, Tennessee, United States
  • Lubbock, Texas, United States
  • Round Rock, Texas, United States
  • Kirkland, Washington, United States
  • Grodno, Belarus
  • Homyel, Belarus
  • Minsk, Belarus
  • Minsk, Belarus
  • Minsk, Belarus
  • Vitebsk, Belarus
  • Vitebsk, Belarus
  • Bruges, Belgium
  • Brussels, Belgium
  • Montegnée, Belgium
  • Banja Luka, Bosnia and Herzegovina
  • + 145 more on CT.gov