A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

• Register: EUCTR
• Last refreshed on: 22 August 2016
• Main ID: EUCTR2011-004580-79-PL
• Date of registration: 12/06/2012
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, New York 10017
• Public title: A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.
• Scientific title: A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS
• Date of first enrolment: 05/08/2012
• Target sample size: 654
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004580-79
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Hungary, India, 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

Contacts

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

• Name: Clinical Trials.gov Call Center
• Affiliation: Pfizer Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects who met study entry criteria and completed 9-week induction treatment from Study A3921094 or A3921095.
2. Subjects who achieved clinical response in Study A3921094 or A3921095.
- Clinical response is defined by a decrease from the induction study baseline (A3921094 or A3921095) 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. For eligibility assessment, clinical response will be determined based on the central-read endoscopy performed at Week 8 of Study A3921094 or A3921095 and the central-read endoscopy performed at Week 0 of Study A3921094 or A3921095.
3. Women of childbearing potential must test negative for pregnancy prior to study enrollment.
- Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 4 weeks after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, bowel movement diary calls and other study procedures.
5. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 534
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion criteria:
1. Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095.
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 concomitant medications, including medications that are either moderate to potent CYP3A inducers or inhibitors, during the study period as specified in Appendix 2 of 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 drug.
6. Women who are pregnant or breastfeeding, 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 (ie, baseline QTcF >450 ms, complete LBBB, acute or indeterminate age myocardial infarction, 2nd-3rd degree AV block, or serious bradyarrhythmias or tachyarrhythmias; see Appendix 4 of the protocol.
8. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
9. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
10. 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.
11. Subjects who are participating in or interested in participating in other investigational studies during study A3921096.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ulcerative colitis
MedDRA version: 18.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: CP-690,550-10
Product Code: CP-690,550-10
Pharmaceutical Form: Tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Other descriptive name: tofacitinib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Primary endpoint is the proportion of subjects in remission at Week 52.

Primary end point(s): The proportion of subjects in remission at Week 52. Remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.

Main Objective: To demonstrate the efficacy of tofacitinib as maintenance therapy in subjects with UC.

Secondary Objective: - To evaluate the safety and tolerability of tofacitinib as maintenance therapy in subjects with UC.
- To evaluate the efficacy of tofacitinib maintenance therapy in achieving mucosal healing in subjects with UC.
- To evaluate the tofacitinib pharmacokinetic exposure during maintenance therapy in subjects with UC.
- To evaluate the effect of tofacitinib as maintenance therapy on quality-of-life in subjects with UC.

Secondary Outcome(s)

Secondary end point(s): Key Secondary Endpoint:
- The proportion of subjects with mucosal healing at Week 52. Mucosal healing is defined by a Mayo endoscopic subscore of 0 or 1.
- The proportion of subjects in sustained steroid-free remission among subjects in remission at baseline of Study A3921096. Sustained steroid-free remission is defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free
remission is defined by being in remission (a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0) in addition to not requiring any treatment with corticosteroid for at least 4 weeks prior to the visit. Other secondary, exploratory, pharmacokinetic, biomarker, Health Outcome and safety endpoints are described within the protocol.

Timepoint(s) of evaluation of this end point: Secondary endpoints are measured at Weeks 24 and 52.

Secondary ID(s)

A3921096

2011-004580-79-DK

Source(s) of Monetary Support

Pfizer Inc.