A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis

Conditions: lcerative colitis (UC)
MedDRA version: 14.1Level: LLTClassification code 10045282Term: UCSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-004581-14-IT

Lead Sponsor: PFIZER LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 725

Inclusion Criteria

1. Subjects previously participated in Study A3921096 who either: a)completed 52 week maintenance treatment in Study A3921096, or b) were early withdrawals from Study A3921096 and met treatment failure criteria defined by an increase in Mayo score of at least 3 points from baseline value of the maintenance study (A3921096), accompanied by an increase in rectal bleeding subscore by at least 1 point, and an increase of endoscopic subscore of at least 1 point (yielding an absolute endoscopic subscore of =2), after a minimum of 8 weeks of treatment in the maintenance study. Note, endoscopic subscores based on central reading will be used to assess treatment failure. 2. Subjects who previously participated in the induction Study A3921094 or A3921095 who: a)did not demonstrate clinical response after completing 8 weeks of treatment. Clinical response is defined by a decrease from baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1, and b)have an endoscopic subscore at Week 8 that is either the same or higher (worse) than the endoscopic subscore at Week 0 of Study A3921094 or A3921095. 3. Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 28 days after the last dose of assigned treatment. 4. Women of childbearing potential must have a negative pregnancy test prior to study enrollment. 5. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 595
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

1. Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096. 2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease. 3. 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. 4. Subjects who are expected to receive any of prohibited medications, including medications that are either moderate to potent CYP3A inducers or inhibitors, during the study period as specified in the protocol. 5. Subjects who are expected to receive live or attenuated virus vaccination during study period and for 6 weeks after last dose of study medication. 6. Women who are pregnant or lactating, or planning to become pregnant during the study period. 7. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results. 8. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures. 9. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 10. Subjects who are or interested in participating in other investigational studies during study participation.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability of long-term CP 690,550 therapy in subjects with UC.;Secondary Objective: - To evaluate the efficacy of long term CP 690,550 therapy in subjects with UC. - To evaluate the effect of long term CP 690,550 therapy on quality-of-life in subjects with UC.;Primary end point(s): - As this is an open label extension study, there will be no primary efficacy endpoint - Incidence and severity of adverse events.;Timepoint(s) of evaluation of this end point: Ongoing incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method

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