You are here

Our science / Clinical Trials / Find a Trial / NCT01393899

The Safety And Efficacy Of Maintenance Therapy With CP-690,550

Back to Search Print Save as PDF Bookmark Trial

NCT01393899

Last updated on May 10, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
ACMG Endoscopy Center
Anaheim, California, 92801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 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 who completed Week 8 visit of Induction
Study A3921083.

- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or
clinical remission (CDAI

- Women of childbearing potential must test negative for pregnancy prior to study
enrolment.

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 the
A3921083 study.

- Subjects likely to require any type of surgery during the study period.

- Fecal culture/toxin assay indicating presence of pathogenic infection.

NCT01393899
Pfizer
Completed
The Safety And Efficacy Of Maintenance Therapy With CP-690,550

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.
Advanced Search

Similar Trials

Type 1 Gaucher Disease
Pharmacokinetics, Pharmacodynamics And Safety Study Of Elelyso(tm) In Pediatric Subjects With Type 1 Gaucher Disease
NCT03021941
All Genders
0+
Years
Multiple Sites
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
NCT03248882
All Genders
18+
Years
Multiple Sites
Chronic Renal Failure, Chronic Kidney Disease
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
NCT01473420
All Genders
18+
Years
Multiple Sites
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease
NCT02433158
All Genders
6+
Years
Multiple Sites
The Safety And Efficacy Of Maintenance Therapy With CP-690,550
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: Placebo
    oral tablets twice daily
  • Drug: CP-690,550
    oral tablets twice daily
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
  • Experimental: 5mg BID
    Intervention: Drug: CP-690,550
  • Experimental: 10mg 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.
 
Completed
180
July 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
  • Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
  • Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Exclusion Criteria:

  • Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
  • Subjects likely to require any type of surgery during the study period.
  • Fecal culture/toxin assay indicating presence of pathogenic infection.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Japan,   Korea, Republic of,   Netherlands,   South Africa,   Spain,   Ukraine,   United States
Croatia,   India
 
NCT01393899
A3921084
2011-001754-28 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

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