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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: October 21, 2011
Last updated: August 16, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Ulcerative Colitis
Drug: Placebo
Drug: CP690,550
Drug: CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Oral CP-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects in remission at Week 52 [ Time Frame: week 52 ]

Secondary Outcome Measures:
  • The proportion of subjects with mucosal healing at Week 52 [ Time Frame: week 52 ]
  • The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096 [ Time Frame: week 24 & 52 ]

Enrollment: 593
Study Start Date: July 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Comparator Drug: Placebo
Placebo 10 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 5 mg Arm Drug: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 10 mg Arm Drug: CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01458574

  Show 281 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01458574     History of Changes
Other Study ID Numbers: A3921096
2011-004580-79 ( EudraCT Number )
OCTAVESUSTAIN ( Other Identifier: Alias Study Number )
Study First Received: October 21, 2011
Last Updated: August 16, 2016

Keywords provided by Pfizer:
Janus kinase inhibitor
JAK 3 inhibitor
inflammatory bowel disease
ulcerative colitis

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017