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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01458574
First received: October 21, 2011
Last updated: July 28, 2014
Last verified: July 2014

October 21, 2011
July 28, 2014
July 2012
March 2016   (final data collection date for primary outcome measure)
The proportion of subjects in remission at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01458574 on ClinicalTrials.gov Archive Site
  • The proportion of subjects with mucosal healing at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096 [ Time Frame: week 24 & 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects with mucosal healing at Week 52. [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096. [ Time Frame: week 24 & 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Oral CP-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: Placebo
    Placebo 10 mg orally (PO) twice a day (BID)
  • Drug: CP690,550
    CP-690,550 5 mg orally (PO) twice a day (BID)
  • Drug: CP-690,550
    CP-690,550 10 mg orally (PO) twice a day (BID)
  • Placebo Comparator: Placebo Comparator
    Intervention: Drug: Placebo
  • Experimental: CP-690,550 5 mg Arm
    Intervention: Drug: CP690,550
  • Experimental: CP-690,550 10 mg Arm
    Intervention: Drug: CP-690,550
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
654
April 2016
March 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom
 
NCT01458574
A3921096
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP