You are here

Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

Last updated on July 19, 2018

FOR MORE INFORMATION
Study Location
Alabama Medical Group, P.C.
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
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 completed induction studies A3921094 or A3921095 and were classified as
not meeting clinical response criteria; OR

- Subjects who completed maintenance study A3921096 or who discontinued treatment early
in Study A3921096 due to treatment failure.

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

- Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.

- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease.

- Subjects who have had surgery for ulcerative colitis or in the opinion of the
investigator, are likely to require surgery for ulcerative colitis during the study
period.

NCT01470612
Pfizer
Active, not recruiting
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Ulcerative Colitis
NCT01470612
All Genders
18+
Years
Multiple Sites
Ulcerative Colitis
NCT03281304
All Genders
18+
Years
Multiple Sites
Ulcerative Colitis
NCT03269695
All Genders
18+
Years
Multiple Sites
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
A Multi-center, Open-label Study Of Cp-690,550 In Subjects With Moderate To Severe Ulcerative Colitis
This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: CP-690,550
    5 mg tablets, BID, for at least 12 months
  • Drug: CP-690,550
    10 mg tablets, BID, for at least 12 months
  • Experimental: CP-690,550 5 mg BID
    5 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550 10 mg BID
    10 mg BID
    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
900
July 27, 2018
July 27, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
  • Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

  • Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
  • Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Austria,   Belgium,   Brazil,   Canada,   Colombia,   Croatia,   Czechia,   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
Czech Republic,   India
 
NCT01470612
A3921139
2011-004581-14 ( EudraCT Number )
OCTAVEOPEN ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now