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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
330
75 mg sterile liquid injected subcutaneously every 4 weeks.
225 mg sterile liquid injected subcutaneously every 4 weeks.
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)
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.
Time frame: From start of study drug administration up to 168 weeks
Percentage of Participants With Mucosal Healing at 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.
Time frame: Week 16
Serum Trough Concentrations of SHP647 Versus Time
Serum trough concentrations of SHP647 versus time was reported.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
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.
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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
...and 89 more locations
Time frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Number of Participants With Positive Neutralizing Antibodies (NAb)
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.
Time frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156