A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis (OCTAVE)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Ulcerative Colitis

Treatments: Drug: CP-690,550; Drug: CP690,550; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01458574

OCTAVESUSTAIN (Other Identifier)

A3921096

2011-004580-79 (EudraCT Number)

Details and patient eligibility

About

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

Enrollment: 593 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
• Subjects who achieved clinical response in Study A3921094 or A3921095
• Women of childbearing potential must test negative for pregnancy prior to study enrollment
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
• Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

• Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
• Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

593 participants in 3 patient groups, including a placebo group

Placebo Comparator

Placebo Comparator group

Treatment:

Drug: Placebo

CP-690,550 5 mg Arm

Experimental group

Treatment:

Drug: CP690,550

CP-690,550 10 mg Arm

Experimental group

Treatment:

Drug: CP-690,550