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 composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Aged 18 to 75 years (at screening for Cohort 1 and 2)
UC confirmed on endoscopy
Moderately to severely active UC (May score 6-12)
Currently receiving treatment with aminosalisylate, prednisone, or budesonide
Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization
You may not be if
Have severe extensive colitis as evidence by:
Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.
Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.
Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis
Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk
History of uveitis or unknown macular edema
Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening
Clareo Health | Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
