Long-Term Safety Of PF-00547659 In Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: 75mg SHP647 (PF-00547659)Drug: 225mg SHP647 (PF-00547659)
- Registration Number
- NCT01771809
- Lead Sponsor
- Shire
- Brief Summary
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- Subjects between 18 and 66 years of age.
- Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.
- 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.
- Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHP647 75 mg 75mg SHP647 (PF-00547659) Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. SHP647 225 mg 225mg SHP647 (PF-00547659) Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) From start of study drug administration up to 168 weeks An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Mucosal Healing at Week 16 Week 16 Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment \[PGA\]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Serum Trough Concentrations of SHP647 Versus Time Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156 Serum trough concentrations of SHP647 versus time was reported.
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) Baseline, Week 8, 16, 24, 40, 48, 64 and 156 The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. The number of participants with positive ADA was reported.
Number of Participants With Positive Neutralizing Antibodies (NAb) Baseline, Week 8, 16, 24, 40, 48, 64 and 156 The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (\>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64.
Trial Locations
- Locations (99)
Mayo Clinic Arizona - Scottsdale
🇺🇸Scottsdale, Arizona, United States
UCSD Altman Clinical and Translational Research Institute
🇺🇸La Jolla, California, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Rocky Mountain Gastroenterology
🇺🇸Thornton, Colorado, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Bassan and Bloom M.D.s
🇺🇸Miramar, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Atlanta Gastroenterology Specialists, PC
🇺🇸Suwanee, Georgia, United States
Scroll for more (89 remaining)Mayo Clinic Arizona - Scottsdale🇺🇸Scottsdale, Arizona, United States