This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
944
5 mg tablets, BID, for at least 12 months
10 mg tablets, BID, for at least 12 months
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.
Time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)
Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Laboratory Test Abnormalities
Laboratory abnormalities: Hemoglobin, hematocrit, RBC: \<0.8\* LLN; reticulocytes (absolute \[Abs\], %): \<0.5\* LLN, \>1.5\* ULN; MCV, MCH: \<0.9\* LLN, \>1.1\* ULN; platelets:\<0.5\* LLN, \>1.75\* ULN; WBC:\<0.6\* LLN,\>1.5\* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):\<0.8\* LLN, \>1.2\* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):\>1.2\* ULN; total bilirubin,direct bilirubin,indirect bilirubin:\>1.5\* ULN; AST,ALT,gamma GT, LDH,ALP: \>3.0\* ULN; total protein,albumin: \<0.8\* LLN,\>1.2\* ULN: BUN,creatinine: \>1.3\* ULN;uric acid:\>1.2\* ULN; cholesterol,triglycerides: \>1.3\* ULN; cholesterol (HDL: \<0.8\* LLN; LDL: \>1.2\* ULN); sodium: \<0.95\* LLN, \>1.05\* ULN; potassium, chloride, calcium, bicarbonate: \<0.9\* LLN, \>1.1\* ULN; glucose: \<0.6\* LLN; creatine kinase \>2.0\* ULN; urine specific gravity: \<1.003; urine pH: \<4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): \>=1; Urine (RBC,WBC): \>=20; urine epithelial cells:\>=6; urine (casts,granular casts,hyaline casts): \>1; urine bacteria:\>20.
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Alabama Medical Group, P.C.
Mobile, Alabama, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
Desert Sun Gastroenterology
Tucson, Arizona, United States
Desert Sun Surgery Center
Tucson, Arizona, United States
Altman Clinical and Translational Research Institute
La Jolla, California, United States
Perlman Medical Offices - UC San Diego Health System
La Jolla, California, United States
UCSD Medical Center
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Cedars Sinai Surgery Center
Los Angeles, California, United States
Alliance Clinical Research
Oceanside, California, United States
...and 242 more locations
Time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Vital Sign Abnormalities
Vital sign abnormalities included greater than or equal to (\>=) 30 millimeter of mercury \[mmHg\] increase in systolic blood pressure (BP), \>=30 mmHg decrease in systolic BP, Systolic BP (less than \[\<\] 90 mmHg), \>=20 mmHg increase in diastolic BP, \>=20 mmHg decrease in diastolic BP, diastolic BP (\<50 mmHg), pulse rate (\<40 beats per minute \[BPM\]), pulse rate (greater than \[\>\] 120 BPM).
Time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline
Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.
Time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Electrocardiogram (ECG) Abnormalities
ECG abnormalities criteria: maximum PR interval (\>=300 millisecond); maximum QRS complex (\>=200 millisecond); and maximum QT interval (\>=500 millisecond).
Time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event \[MACE\]), malignancy (non-melanoma skin cancer \[NMSC\], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).
Time frame: Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases
Remission in participants was defined as a total Mayo score of less than or equals to (\<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time frame: Months 2, 12, 24 and 36
Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Remission in participants was defined as a total Mayo score of \<=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time frame: Months 2, 12, 24 and 36
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases
Clinical remission in participants was defined as a total Mayo score of \<=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time frame: Months 2, 12, 24 and 36
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Clinical remission in participants was defined as a total Mayo score of \<=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.
Time frame: Months 2, 12, 24 and 36
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases
PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score \<=2 with no individual sub score \>1.
Time frame: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score \<=2 with no individual sub score \>1.
Time frame: Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases
Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.
Time frame: Months 2, 12, 24 and 36
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity.
Time frame: Months 2, 12, 24 and 36
Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)
IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.
Time frame: Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84