Study to test the long term safety of PF-00547659 in subjects with Ulcerative Colitis
- Conditions
- lcerative Colitis (UC)MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-002031-28-BE
- Lead Sponsor
- Shire Human Genetic Therapies, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 331
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 A7281009 who have completed the blinded 84-day (12-week) induction period.
2.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.
3.Male and/or female subjects between the ages of 18 and older and 66 years and younger at the time of informed consent if they were previously enrolled in study A7281009.
4. 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).
5. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the duration of the study (defined as the time of the signing of the ICD through the conclusion of onsite subject participation or for approximately 6 months from the last dose of investigational product for any subject who discontinues early from the study). A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
•Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at baseline. WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
• Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria:
• Have undergone hysterectomy or bilateral oophorectomy;
• Have medically confirmed ovarian failure; or
• Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).
6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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 231
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
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 A7281009 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. Males and females of childbearing potential not using higly effective contraception or not agreeing to continue highly effective contraception through the conclusion of onsite subject participation or for approximately 6 months from the last dose of investigational product for any subject who discontinues early from the study).
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 study A7281009 that, in the opinion of the investigator, compromised the safety or efficacy of this study.
8. Planned live (attenuated) vaccination during the course of the study.
9. Planned major elective medical or surgical procedure during the course of this study.
10. Participation in other interventional studies during participation in this study.
11. The inability to complete any of the five neurological assessments without a clear explanation (e.g. broken leg, sprained wrist, etc).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To monitor the safety and tolerability of PF-0547659 during long-term treatment. ;Secondary Objective: The secondary objective is to assess pharmacokinetics and immunogenicity of PF-0547659 <br><br>Exploratory Objective<br><br>Assessment of the durability of response with long-term treatment with PF-00547659 based upon Clinical Remission and Clinical Response based upon the Mayo Score performed at Week 16 in Clinical Responders from study A7281009.<br><br>Explore relationships between PK pf PF-00547659, PD and clinical endpoints. <br>;Primary end point(s): Safety <br>Frequency of on-treatment AEs, AEs leading to withdrawal, and SAEs. <br>;Timepoint(s) of evaluation of this end point: All visits
- Secondary Outcome Measures
Name Time Method