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

NCT01458574

Last updated date
Study Location
Internal Medicine Center, LLC
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Pfizer Clinical Trials Contact Center

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  24. New York, New York
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  26. New York, New York
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Official Title  ICMJE A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2016)
593
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
654
Actual Study Completion Date  ICMJE May 27, 2016
Actual Primary Completion Date May 27, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01458574
Other Study ID Numbers  ICMJE A3921096
2011-004580-79 ( EudraCT Number )
OCTAVESUSTAIN ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2017

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