A7281007; Multi-center open-label extension study for PF-00547659

• Register: EUCTR
• Last refreshed on: 8 August 2016
• Main ID: EUCTR2010-024638-48-DE
• Date of registration: 30/05/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
• Public title: A7281007; Multi-center open-label extension study for PF-00547659
• Scientific title: A MULTICENTER OPEN-LABEL EXTENSION STUDY TO ASSESS LONG-TERM SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA II) - OPERA II
• Date of first enrolment: 22/02/2012
• Target sample size: 210
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024638-48
• Study type: Interventional clinical trial of medicinal product
• Study design: 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: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Canada, Croatia, France, Germany, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, South Africa, Spain, Sweden, United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in this study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:
1. Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed week 12 and have demonstrated a clinical response as defined by that protocol.
2. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
3. All women of childbearing potential (WOCBP) as determined during the feeder study (data must be available as source documents for this study) must have a negative urine pregnancy test result at the Baseline visit and throughout the duration of this study (defined as the time of the signing of the ICD through the end of this study).
• Women of non childbearing potential (WONCBP) as determined during the previous study do not require urine pregnancy tests in this study.
4. WOCBP who have sexual intercourse with a non surgically sterilized male partner must agree and commit to the use one of the following highly effective methods of contraception for the duration of the study (defined as the time of the signing of the ICD through the conclusion of subject participation or for approximately 6 months from the last dose of investigational product for any subject who discontinues early from the study). Contraceptive methods considered acceptable for use in this study include:
a. Established use [=2 months prior to the screening visit] of oral, injected, transdermal or implanted hormonal methods of contraception. Subjects who have used such methods for less than 2 months at the screening visit are required to use one of the methods described under b) or c) until the establishment of hormonal contraception methods.
b. Double barrier contraception: use of occlusive diaphragm (cap or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. In countries that spermicidal condoms are not allowed ordinary condoms could be used in combination with spermicidal creams. Appropriate measures are to be determined by the investigator together with the subject, in accordance with the standard of care in the country where treatment is administered. A female condom and a male condom should not be used together as friction between the two can result in either, or both product(s) failing. Appropriate measures are to be determined by the investigator together with the subject, in accordance with the standard of care in the country where treatment is administered.
c. An intrauterine device or system.
5. All men (unless surgically sterile, as defined below) who have sexual intercourse with a WOCBP must agree and commit to use a highly effective method of contraception as described under WOCBP for the duration of this study (defined as the time of the signing of the ICD through the conclusion of subject participation or for 6 months from the last dose of investigational product for any subject who terminates early from this study). Highly effective methods of contraception include properly used spermicidal condom.
6. To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks or bi lateral orchiectomy >30 days befo
Exclusion criteria:
Subjects presenting with any of the following will not be included in this study:
1. Subjects that have completed Day 84 (Week 12) of study A7281006 or completed Day 85 (Week 12) of study A7281008 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study.
2. Subjects who are taking any dose of AZA, 6 MP or MTX.
3. Pregnant or breastfeeding women.
4. Entero vesicular (ie, between the bowel and urinary bladder) fistulae are prohibited. Other fistulae are allowed (e.g., enterocutaneous fistulae). Documentation of active and inactive fistulae are required.
5. Evidence of right or left heart failure based on echocardiographic assessments conducted as part of a prior study of PF-00547659.
6. 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 entry into this study.
7. Received any prohibited treatment during the feeder study that, in the opinion of the investigator, compromised the safety or efficacy of this study.
8. Planned live (attenuated) vaccination during the course of this study.
9. Subjects with known allergy or hypersensitivity to PF-00547659 or its components.
10. Planned major elective medical or surgical procedure during the course of this study.
11. Participation in other interventional studies during participation in this study.
12. The inability to complete any of the five neurological assessments.


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

Health Condition(s) or Problem(s) studied

Crohn’s disease
MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

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

Intervention(s)

Product Name: Not Applicable
Product Code: PF-00547659
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not applicable
Current Sponsor code: PF-00547659
Other descriptive name: Not applicable
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-

Primary Outcome(s)

Main Objective: • The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long-term treatment.

Secondary Objective: •The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.
•Exploratory objectives include an assessment of the durability of response with long term treatment with PF-00547659.
•To determine the effect of PF-00547659 on disease biology in lesional and nonlesional tissue obtained by endoscopy.
• To determine the effects of PF-00547659 on mucosal healing

Timepoint(s) of evaluation of this end point: All visits

Primary end point(s): Frequency of on-treatment AEs, AEs leading to withdrawal, and SAEs

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: ADAs: visits: 1, 2, 5, 8, 11, 14, 17, 20, 21, 22, 23, 24, 25, Early Withdrawal

PK - all visits

Secondary end point(s): Immunogenicity
• Frequency of the development of anti-drug antibodies (ADAs).
Pharmacokinetics
• Plasma trough concentrations of PF 00547659 will be summarized along with listings and plots, and may further be analyzed using Population PK methodology.

Secondary ID(s)

A7281007

2010-024638-48-SK

NCT01298492

Source(s) of Monetary Support

Pfizer Inc