Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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10 February 2014 |
Main ID: |
EUCTR2011-004581-14-IT |
Date of registration:
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07/08/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis
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Scientific title:
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A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS |
Date of first enrolment:
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18/01/2013 |
Target sample size:
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725 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004581-14 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
Number of treatment arms in the trial: 1
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Phase:
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Countries of recruitment
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Australia
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Austria
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Brazil
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Canada
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Colombia
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Czech Republic
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Denmark
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Estonia
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Germany
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Hungary
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India
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Israel
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Italy
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Japan
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Korea, Republic of
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Latvia
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Netherlands
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Russian Federation
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South Africa
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Spain
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Taiwan
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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ICON Clinical ResearchStartUp Team
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Address:
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Concept House, 6 Stoneycroft Rise, Chandlers Ford
S053 3LD
Eastleigh, Hampshire
United Kingdom |
Telephone:
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+44 (0) 2380 688500 |
Email:
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kellie.macleod@iconplc.com |
Affiliation:
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Pfizer Limited, Ramsgate Road, Sandwick, Kent, UK |
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Name:
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ICON Clinical ResearchStartUp Team
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Address:
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Concept House, 6 Stoneycroft Rise, Chandlers Ford
S053 3LD
Eastleigh, Hampshire
United Kingdom |
Telephone:
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+44 (0) 2380 688500 |
Email:
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kellie.macleod@iconplc.com |
Affiliation:
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Pfizer Limited, Ramsgate Road, Sandwick, Kent, UK |
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Ulcerative colitis (UC) MedDRA version: 14.1
Level: LLT
Classification code 10045282
Term: UC
System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1
Level: SOC
Classification code 10017947
Term: Gastrointestinal disorders
System Organ Class: 10017947 - Gastrointestinal disorders
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Intervention(s)
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Product Name: NA 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-
Product Name: NA 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-
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Primary Outcome(s)
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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.
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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.
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Main Objective: To assess the safety and tolerability of long-term CP 690,550 therapy in subjects with UC.
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Timepoint(s) of evaluation of this end point: Ongoing incidence and severity of adverse events
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Secondary endpoints are measured at Months 2, 12, 24 and 36.
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Secondary end point(s): • Proportion of subjects in remission at Months 2, 12, 24 and 36. • Proportion of subjects in remission at Months 2, 12, 24, and 36 among four subgroups of subjects based on the status at baseline of Study A3921139: 1) in remission, 2) treatment failure, 3) all other subjects from study A3921096 neither in remission nor fulfilling the definition of treatment failure, and 4) non responders from induction studies A3921094 or A3921095. • Proportion of subjects in partial Mayo score (PMS) remission over time. • Proportion of subjects in PMS remission over time among the four subgroups of subjects described above. • PMS and change from Baseline (of Study A3921139) over time. • Proportion of subjects who achieve mucosal healing at Months 2, 12, 24 and 36. • Proportion of subjects with total score in IBDQ =170 over time. • Incidence of serious infections. - Other secondary, exploratory, pharmacokinetic, biomarker, Health Outcome and safety endpoints are described within the protocol
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Secondary ID(s)
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2011-004581-14-CZ
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A3921139
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Source(s) of Monetary Support
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Pfizer Limited
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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