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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: EUCTR
Last refreshed on: 12 December 2016
Main ID:  EUCTR2011-003622-27-GR
Date of registration: 24/05/2012
Prospective Registration: Yes
Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, New York 10017
Public title: A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE
Scientific title: A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE
Date of first enrolment: 05/06/2012
Target sample size: 60
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003622-27
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: CP-690,550 Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Australia Austria Bulgaria Canada Croatia Czech Republic France Germany
Greece Hungary India Israel Netherlands Norway Romania Slovakia
South Africa Spain Sweden Ukraine United States
Contacts
Name: Clinical Trials.gov Call Center   
Address:  235 East 42nd Street NY 10017 New York United States
Telephone: 0018007181021
Email: clinicaltrials.govcallcenter@pfizer.com
Affiliation:  Pfizer Inc
Name: Clinical Trials.gov Call Center   
Address:  235 East 42nd Street NY 10017 New York United States
Telephone: 0018007181021
Email: clinicaltrials.govcallcenter@pfizer.com
Affiliation:  Pfizer Inc
Key inclusion & exclusion criteria
Inclusion criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure
2. Women of childbearing potential must test negative for pregnancy prior to study enrolment.
3. Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation (Further description of the requirements and a list of contraceptives considered effective and acceptable for use in this trial are found in Section 4.4 Life Style Guidelines of the protocol).
4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
5. Evidence of a personally signed and dated informed consent document(s) indicating that the subject 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 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
Subjects presenting with any of the following will be excluded from the study:
1. Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
2. Subjects who were discontinued from the A3921084 study due to an adverse event.
3. Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
4. Evidence of active (draining) fistulae, intrabdominal or perineal collection or abscess at Baseline (MRI imaging is not required for entry to this study unless clinically indicated).
5. Subjects with evidence of or suspected liver disease ie, liver injury due to methotrexate or primary sclerosing cholangitis.
6. Subjects with evidence of blood dyscrasias at Baseline visit (as assessed by the laboratory results from Week 26 or early discontinuation visit from the A3921084 study):
• Hemoglobin levels <9.0 g/dL or hematocrit <30%.
• An absolute white blood cell (WBC) count of <3.0 x 10 to the power of 9/L (<3000/mm3) or absolute neutrophil count of <1.2 X 10 to the power of 9/L (<1200/mm3).
• Thrombocytopenia, as defined by a platelet count <100 x 10 to the power of 9/L (<100,000/mm3).
7. Subjects who have been scheduled to receive any live or attenuated virus vaccination during study period and for 6 weeks after last dose of study drug. (see Section 4.4.4 of the protocol for further information on avoidance of household contacts who may be vaccinated with live virus).
8. Women who are pregnant or lactating, or planning pregnancy during the study period.
9. Subjects with estimated GFR =40 mL/min based on Cockcroft-Gault calculation from Week 26 or early discontinuation visit from the A3921084 study.
10. Subjects with total bilirubin, AST or ALT more than 1.5 times the upper limit of normal from Week 26 or early discontinuation visit from the A3921084 study.
11. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including uncontrolled hypercholesterolemia), endocrine, pulmonary, cardiac, or neurological disease.
12. Baseline 12-lead ECG (from Week 26 or early discontinuation visit from the A3921084 study) 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 3 of the protocol).
13. Subjects who are expected to receive prohibited concomitant medications (see Appendix 2 of the protocol) including medications that are either moderate to potent CYP3A4 inducers or inhibitors during the study period.
14. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
15. 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.
16. 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 in


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Crohn's Disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Intervention(s)

Product Code: CP-690,550-10
Pharmaceutical Form: Film-coated tablet
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)
Main Objective: The primary objective of the study is to assess the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with CD.
Primary end point(s): Safety Endpoints
- Incidence and severity of adverse events.
- Incidence and severity of clinical laboratory abnormalities, and change from baseline in clinical laboratory values.
- Incidence of clinically significant changes in physical examination from baseline.
- Incidence of vital sign abnormalities and changes from baseline in vital sign measures.
- Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measurements during treatment.
- Summary of adjudicated cardiovascular endpoints.
- Summary of malignancies confirmed by central laboratory pathologist over-read of biopsies.
Secondary Objective: • To evaluate the effect of OL CP-690,550 maintenance therapy on clinical remission in subjects with CD.

• To evaluate the effect of OL CP-690,550 maintenance therapy on quality-of-life in subjects with CD.

• To evaluate the effect of OL CP-690,550 maintenance therapy on biomarkers as measured by CRP and fecal calprotectin.
Timepoint(s) of evaluation of this end point: All safety endpoints are measured at every clinic visit throughout the duration of the study (52 weeks)
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: All efficacy endpoints are measured at times specified in above section.
Secondary end point(s): Efficacy endpoints

- Sustained clinical remission at both Week 24 and Week 48.
- The proportion of all subjects in clinical remission and sustained clinical remission at Week 48.
- The proportions of subjects in clinical remission and sustained clinical remission among subjects in clinical remission at A3921086 baseline.
- The proportion of subjects in clinical remission and sustained clinical remission among subjects in clinical response or clinical remission at A3921086 baseline.
- The median time to relapse among subjects in clinical remission at baseline.
- CDAI scores over time and change from baseline
- The proportion of subjects achieving a steroid-free clinical remission at Week 48.
- Corticosteroid use over time.
- Serum CRP and fecal calprotectin over time and change from baseline.
Secondary ID(s)
2011-003622-27-SE
A3921086
Source(s) of Monetary Support
Pfizer Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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