Long-Term Safety Of PF-00547659 In Ulcerative Colitis (TURANDOT II)
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|ClinicalTrials.gov Identifier: NCT01771809|
Recruitment Status : Completed
First Posted : January 18, 2013
Results First Posted : April 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: 75mg SHP647 (PF-00547659) Drug: 225mg SHP647 (PF-00547659)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)|
|Actual Study Start Date :||March 18, 2013|
|Actual Primary Completion Date :||December 13, 2017|
|Actual Study Completion Date :||December 13, 2017|
Experimental: SHP647 75 mg
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.
Drug: 75mg SHP647 (PF-00547659)
75 mg sterile liquid injected subcutaneously every 4 weeks.
Experimental: SHP647 225 mg
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.
Drug: 225mg SHP647 (PF-00547659)
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) [ Time Frame: 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.
- Percentage of Participants With Mucosal Healing at Week 16 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771809
|Study Director:||Shire Physician||Shire|