A Study To Evaluate Both The Efficacy and Safety Profile... | NCT01458951

NCT01458951

ID	Type	Description	Link
2011-004579-35	EudraCT Number
OCTAVEINDUCTION2	Other Identifier	Alias Study Number

Status Module

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

Outcomes Module

Primary Outcomes

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 . 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 score indicating more severe disease.	Week 8

Secondary Outcomes

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

Eligibility Module

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

Facility	Status	City	State	ZIP	Country	Contacts
Desert Sun Clinical Research, LLC		Tucson	Arizona	85710	United States
Desert Sun Gastroenterology

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38778549	Derived	Panes J, D'Haens GR, Sands BE, Ng SC, Lawendy N, Kulisek N, Guo X, Wu J, Vranic I, Panaccione R, Vermeire S. Analysis of tofacitinib safety in ulcerative colitis from the completed global clinical developmental program up to 9.2 years of drug exposure. United European Gastroenterol J. 2024 Jul;12(6):793-801. doi: 10.1002/ueg2.12584. Epub 2024 May 22.
38425446

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

Results Section

Participant Flow Module

Arm/Group Information

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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

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

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 . 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 score indicating more severe disease.

Full analysis set included all participants who were 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	OG000429 OG001112

Title

Denominators

Categories

Title	Measurements
	OG00016.6 OG0013.6

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. Percentage difference and its 95% CI was based on normal approximation for the difference in binomial proportions. Missing data were imputed using non-responder imputation (NRI).	CMH Chi-square Test		0.0005		Percentage difference	13.0			2-Sided	95	8.1	17.9				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.

Full analysis set included all participants who were 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 sub score of at least 1 point or an absolute rectal bleeding sub score 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 flexible centrally read 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 score indicating more severe disease.

Full analysis set included all participants who were 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

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.

Full analysis set included all participants who were 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 flexible centrally read 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 score indicating more severe disease.

Full analysis set included all participants who were 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 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 flexible centrally read 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 score indicating more severe disease.

Full analysis set included all participants who were 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 flexible centrally read 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 score indicating more severe disease.

Full analysis set included all participants who were 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

Partial Mayo Scores

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

Full analysis set included all participants who were 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

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) ranges 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 graded 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 Score 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 flexible centrally read 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 score 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

Arm/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.	18	429	68	429
EG001	Tofacitinib 15 mg BID	Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.	0	6	4	6
EG002	Placebo BID	Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.	9	112	20	112

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0010 affected6 at risk EG0021 affected112 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0002 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Anal fistula	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0010 affected6 at risk EG0021 affected112 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0008 affected429 at risk EG0010 affected6 at risk EG0024 affected112 at risk
Constipation	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0010 affected6 at risk EG0021 affected112 at risk
Proctalgia	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Asthenia	General disorders	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Chills	General disorders	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Furuncle	Infections and infestations	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0010 affected6 at risk EG0021 affected112 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0010 affected6 at risk EG0021 affected112 at risk
Hypertension	Vascular disorders	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0010 affected6 at risk EG0020 affected112 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v.18.0	Non-systematic Assessment	EG00011 affected429 at risk EG0011 affected6 at risk EG0022 affected112 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0007 affected429 at risk EG0010 affected6 at risk EG0026 affected112 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v.18.0	Non-systematic Assessment	EG0007 affected429 at risk EG0011 affected6 at risk EG0020 affected112 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0011 affected6 at risk EG0020 affected112 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v.18.0	Non-systematic Assessment	EG0001 affected429 at risk EG0011 affected6 at risk EG0020 affected112 at risk
Urine analysis abnormal	Investigations	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0011 affected6 at risk EG0020 affected112 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v.18.0	Non-systematic Assessment	EG0007 affected429 at risk EG0011 affected6 at risk EG0020 affected112 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v.18.0	Non-systematic Assessment	EG0000 affected429 at risk EG0011 affected6 at risk EG0020 affected112 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v.18.0	Non-systematic Assessment	EG00011 affected429 at risk EG0010 affected6 at risk EG0026 affected112 at risk
Headache	Nervous system disorders	MedDRA v.18.0	Non-systematic Assessment	EG00033 affected429 at risk EG0010 affected6 at risk EG0029 affected112 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