A Study Evaluating The Efficacy And Safety Of CP-690,550... | NCT01465763

ID	Type	Description	Link
2011-004578-27	EudraCT Number
OCTAVEINDUCTION1	Other Identifier	Alias Study Number

Label	Type	Description	Intervention Names
tofacitinib 10 mg BID	Experimental		Drug: tofacitinib
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
tofacitinib	Drug	10 mg oral BID	tofacitinib 10 mg BID	CP-690,550

Measure	Description	Time Frame
Percentage of Participants With Remission at Week 8	Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.	Week 8

Measure	Description	Time Frame
Percentage of Participants Achieving Mucosal Healing at Week 8	Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.	Week 8

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Internal Medicine Center, LLC		Mobile	Alabama	36608	United States
Springhill Memorial Hospital

PubMed Identifier	Type	Citation	Retractions
38425446	Derived	Rubin DT, Torres J, Regueiro M, Reinisch W, Prideaux L, Kotze PG, Tan FH, Gardiner S, Mundayat R, Cadatal MJ, Ng SC. Association Between Smoking Status and the Efficacy and Safety of Tofacitinib in Patients with Ulcerative Colitis. Crohns Colitis 360. 2024 Jan 20;6(1):otae004. doi: 10.1093/crocol/otae004. eCollection 2024 Jan.
37560161

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
FG001	Tofacitinib 15 mg BID	Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Remission at Week 8

Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

Full analysis set (FAS) included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants	OG000476 OG001122

Title

Denominators

Categories

Title	Measurements
	OG00018.5 OG0018.2

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	P-value based on Cochran-Mantel-Haenszel (CMH) chi-square test stratified by prior treatment with anti-tumor necrosis factor (TNF), steroid use at baseline and geographic region. Difference and its 95% CI based on normal approximation for the difference in binomial proportions. Missing data were imputed using Non-responder imputation (NRI).	CMH Chi-square test		0.0070		Percent Difference	10.3			2-Sided	95	4.3	16.3				No	Superiority or Other

Secondary

Percentage of Participants Achieving Mucosal Healing at Week 8

Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Clinical Response at Week 8

Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts

Secondary

Percentage of Participants With Endoscopic Remission at Week 8

Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Clinical Remission at Week 8

Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants

Secondary

Percentage of Participants With Symptomatic Remission at Week 8

Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts

Secondary

Percentage of Participants With Deep Remission at Week 8

Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.

Posted

Number

percentage of participants

Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants

Secondary

Partial Mayo Scores

A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.

FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Weeks 2, 4, 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8

Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Weeks 2, 4, 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants

Secondary

Change From Baseline in Total Mayo Scores at Week 8

Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 8

ID	Title	Description
OG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
OG001	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA v18.0	Non-systematic Assessment	EG0005 affected476 at risk EG0010 affected16 at risk EG0022 affected122 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Malaise	General disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Anal abscess	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Cellulitis	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Clostridium difficile infection	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Febrile infection	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Otitis externa	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Pneumonia	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0010 affected16 at risk EG0021 affected122 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Vulva cyst	Reproductive system and breast disorders	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0010 affected16 at risk EG0021 affected122 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0010 affected16 at risk EG0021 affected122 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Aortic dissection	Vascular disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk
Temporal arteritis	Vascular disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0010 affected16 at risk EG0020 affected122 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v18.0	Non-systematic Assessment	EG00011 affected476 at risk EG0011 affected16 at risk EG0026 affected122 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA v18.0	Non-systematic Assessment	EG0006 affected476 at risk EG0011 affected16 at risk EG0023 affected122 at risk
Flatulence	Gastrointestinal disorders	MedDRA v18.0	Non-systematic Assessment	EG0002 affected476 at risk EG0011 affected16 at risk EG0021 affected122 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Nausea	Gastrointestinal disorders	MedDRA v18.0	Non-systematic Assessment	EG00015 affected476 at risk EG0011 affected16 at risk EG0025 affected122 at risk
Fatigue	General disorders	MedDRA v18.0	Non-systematic Assessment	EG00010 affected476 at risk EG0011 affected16 at risk EG0024 affected122 at risk
Pyrexia	General disorders	MedDRA v18.0	Non-systematic Assessment	EG00014 affected476 at risk EG0011 affected16 at risk EG0023 affected122 at risk
Folliculitis	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0009 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Gastroenteritis	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0007 affected476 at risk EG0011 affected16 at risk EG0022 affected122 at risk
Nasopharyngitis	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG00034 affected476 at risk EG0013 affected16 at risk EG0029 affected122 at risk
Sinusitis	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG0002 affected476 at risk EG0012 affected16 at risk EG0021 affected122 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v18.0	Non-systematic Assessment	EG00015 affected476 at risk EG0011 affected16 at risk EG0021 affected122 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v18.0	Non-systematic Assessment	EG00012 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Liver function test abnormal	Investigations	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v18.0	Non-systematic Assessment	EG0002 affected476 at risk EG0011 affected16 at risk EG0022 affected122 at risk
Headache	Nervous system disorders	MedDRA v18.0	Non-systematic Assessment	EG00037 affected476 at risk EG0010 affected16 at risk EG0028 affected122 at risk
Anxiety	Psychiatric disorders	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Depressed mood	Psychiatric disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0011 affected16 at risk EG0021 affected122 at risk
Dysuria	Renal and urinary disorders	MedDRA v18.0	Non-systematic Assessment	EG0001 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Haematuria	Renal and urinary disorders	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA v18.0	Non-systematic Assessment	EG00010 affected476 at risk EG0013 affected16 at risk EG0020 affected122 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v18.0	Non-systematic Assessment	EG0005 affected476 at risk EG0011 affected16 at risk EG0021 affected122 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk
White blood cell count increased	Investigations	MedDRA v18.0	Non-systematic Assessment	EG0000 affected476 at risk EG0011 affected16 at risk EG0020 affected122 at risk

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases

ID	Title	Description
BG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
BG001	Tofacitinib 15 mg BID	Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
BG002	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tofacitinib 10 mg BID	Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	16	476	148	476
EG001	Tofacitinib 15 mg BID	Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.	0	16	12	16
EG002	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.	5	122	38	122