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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03281304

Registration number

NCT03281304

Ethics application status

Date submitted

11/09/2017

Date registered

13/09/2017

Date last updated

21/03/2023

Titles & IDs

Public title

A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

Scientific title

A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

Secondary ID [1]

RIVETING STUDY

Secondary ID [2]

A3921288

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Ulcerative Colitis

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Inflammatory and Immune System

Other inflammatory or immune system disorders

Oral and Gastrointestinal

Inflammatory bowel disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - CP-690,500 5 mg
Treatment: Drugs - CP-690,550 10 mg

Experimental: CP-690,550 5 mg - CP-690,550 5 mg tablet by mouth twice a day (BID)

Experimental: CP-690,550 10 mg - CP-690,550 10 mg BID

Treatment: Drugs: CP-690,500 5 mg
CP-690,550 5 mg tablet BID

Treatment: Drugs: CP-690,550 10 mg
CP-690,550 10 mg tablet BID

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Number of Participants With Remission Based on Modified Mayo Score at Month 6

Assessment method [1]

Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0 at Month 6. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.

Timepoint [1]

Month 6

Secondary outcome [1]

Time to Loss of Remission Based on Modified Mayo Score Using Kaplan-Meier Method

Assessment method [1]

Time to loss of remission(flare): time from first drug administration until time of meeting loss of remission criteria based on modified mayo score. Loss of remission: meeting at least (\>=)1 criteria: increase from Baseline in rectal bleeding subscore by \>=1 point and increase in endoscopic subscore by \>=1 point; increase from Baseline in rectal bleeding subscore by \>=2 points and endoscopic subscore \>0; increase in stool frequency subscore by \>=2 points and increase in endoscopic subscore by \>=1 point; increase in endoscopic subscore by \>=2 points. Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores: Modified mayo score included 3 components: stool frequency, rectal bleeding and endoscopic subscores, each subscore graded from 0 to 3 with higher scores for each score=more severe disease. All scores summed up to give total modified mayo score range from 0 to 9; higher scores=more severe disease.

Timepoint [1]

Up to Month 42

Secondary outcome [2]

Number of Participants With Remission Based on Modified Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Assessment method [2]

Remission as per modified partial mayo score was defined as stool frequency subscore of 0 or 1, and rectal bleeding sub score of 0 at the specified time points. Modified partial mayo scores consisted of 2 components: stool frequency and rectal bleeding: each subscore graded from 0 to 3 with higher scores for each score = more severe disease. These scores were summed up to give a total modified partial mayo score range of 0 to 6; where higher scores indicating more severe disease.

Timepoint [2]

Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Secondary outcome [3]

Number of Participants With Remission Based on Total Mayo Score at Months 6, 18, 30 and 42

Assessment method [3]

Remission as per total mayo score 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 UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.

Timepoint [3]

Months 6, 18, 30 and 42

Secondary outcome [4]

Number of Participants With Remission Based on Partial Mayo Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Assessment method [4]

Remission as per partial mayo score was defined as partial mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.

Timepoint [4]

Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Secondary outcome [5]

Number of Participants With Remission Based on Modified Mayo Score at Months 18, 30 and 42

Assessment method [5]

Remission as per modified mayo score was defined as an endoscopic subscore of 0 or 1, stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0. Modified mayo score consisted of 3 components: stool frequency subscore, rectal bleeding subscore and endoscopic subscore: higher scores for each score = more severe disease. These scores were summed up to give a total modified mayo score range of 0 to 9; where higher scores indicating more severe disease.

Timepoint [5]

Months 18, 30 and 42

Secondary outcome [6]

Change From Baseline in Modified Mayo Score at Month 6

Assessment method [6]

Modified mayo score is an instrument designed to measure disease activity of UC. Modified mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 to 3 with higher scores indicating more severe disease. These individual scores were summed up to give a total modified mayo score range of 0 to 9, where higher scores indicated more severe disease.

Timepoint [6]

Baseline, Month 6

Secondary outcome [7]

Change From Baseline in Modified Mayo Score at Months 18, 30 and 42

Assessment method [7]

Timepoint [7]

Baseline, Months 18, 30 and 42

Secondary outcome [8]

Change From Baseline in Modified Partial Mayo Score at Months 1, 3 and 6

Assessment method [8]

Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total Modified partial mayo score ranges from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.

Timepoint [8]

Baseline, Months 1, 3 and 6

Secondary outcome [9]

Change From Baseline in Modified Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Assessment method [9]

Modified partial mayo scores consisted of 2 subscores: stool frequency and rectal bleeding with each subscore graded from 0 to 3 with higher scores indicating more severe disease. Individual subscores were summed up to give a total modified partial mayo score range from 0 (normal or inactive disease) to 6 (severe disease) with higher scores indicating more severe disease.

Timepoint [9]

Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Secondary outcome [10]

Change From Baseline in Total Mayo Score at Month 6

Assessment method [10]

Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total mayo score range of 0 to 12, where higher scores indicating more severe disease.

Timepoint [10]

Baseline, Month 6

Secondary outcome [11]

Change From Baseline in Total Mayo Score at Months 18, 30 and 42

Assessment method [11]

Timepoint [11]

Baseline, Months 18, 30 and 42

Secondary outcome [12]

Change From Baseline in Partial Mayo Score at Months 1, 3 and 6

Assessment method [12]

Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score range from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.

Timepoint [12]

Baseline, Months 1, 3 and 6

Secondary outcome [13]

Change From Baseline in Partial Mayo Score at Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Assessment method [13]

Partial mayo score was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 subscores: stool frequency, rectal bleeding and PGA with each subscore graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a total partial mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease) with higher scores indicating more severe disease.

Timepoint [13]

Baseline, Months 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Secondary outcome [14]

Number of Participants With Mucosal Healing at Months 6, 18, 30 and 42

Assessment method [14]

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

Timepoint [14]

Months 6, 18, 30 and 42

Secondary outcome [15]

Number of Participants With Clinical Response Based on Mayo Score at Months 6, 18, 30 and 42

Assessment method [15]

Clinical response was defined as 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 flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicating more severe disease. PGA included 3 criteria: participant's recollection of abdominal discomfort, general sense of wellbeing and other observations such as physical findings and performance status. Individual subscores were summed up to give a mayo score range of 0 to 12, where higher scores indicating more severe disease.

Timepoint [15]

Months 6, 18, 30 and 42

Secondary outcome [16]

Change From Baseline in Fecal Calprotectin at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Assessment method [16]

Change from baseline in fecal calprotectin (in micrograms per gram \[mcg/g\]) was reported.

Timepoint [16]

Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Secondary outcome [17]

Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Level at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Assessment method [17]

Change From baseline in hs-CRP level (in milligrams per liter \[mg/L\]) is reported.

Timepoint [17]

Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42

Secondary outcome [18]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Assessment method [18]

An AE was any untoward medical occurrence in a participant who received investigational product 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; medically important events. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both serious and all non-serious adverse events (irrespective of frequency threshold used to report other AEs in safety section).

Timepoint [18]

Baseline up to 43 months

Secondary outcome [19]

Number of Participants With Serious Infections

Assessment method [19]

Serious infections were defined as any infections (viral, bacterial, and fungal) requiring parenteral antimicrobial therapy, hospitalization for treatment, or meeting other criteria that require the infection to be classified as serious adverse event. 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; medically important events.

Timepoint [19]

Baseline up to 43 months

Secondary outcome [20]

Number of Participants With Clinical Laboratory Abnormalities

Assessment method [20]

Abnormality criteria: Hematology: hemoglobin(Hg): \<0.8\* lower limit of normal (LLN); hematocrit: \<0.8\*LLN; lymphocytes: \<0.8\* LLN; lymphocytes/leukocytes: \<0.8\*LLN; erythrocytes: \<0.8\*LLN; erythrocytes mean corpuscular volume: \<0.9\*LLN; erythrocytes mean corpuscular Hg: \<0.9\*LLN; reticulocytes, reticulocytes/erythrocytes:\>1.5\* upper limit of normal (ULN); neutrophils, neutrophils/leukocytes: \>1.2\*ULN; basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes/leukocytes: \>1.2\*ULN; leukocyte esterase: \>=1; Clinical chemistry: bicarbonate:\<0.9\*LLN, bilirubin: \>1.5\*ULN; indirect bilirubin: \>1.5\* ULN; aspartate aminotransferase(AT): \>3.0\*ULN; alanine AT: \>3.0\*ULN; gamma glutamyl transferase: \>3.0\* ULN; creatine kinase: \>2.0\*ULN; potassium: \>1.1\*ULN; blood urea nitrogen: \>1.3\*ULN; creatinine: \>1.3\*ULN; urate: \>1.2\*ULN; cholesterol: \>1.3\*ULN; HDL-cholesterol: \<0.8\* LLN; LDL-cholesterol: \>1.2\*ULN; triglycerides: \>1.3\*ULN; glucose: \>1.5\*ULN; and urine Hg \>=1.

Timepoint [20]

Baseline up to 27 months

Secondary outcome [21]

Number of Participants With Clinically Significant Laboratory Abnormalities Leading to Study Treatment Discontinuation

Assessment method [21]

Laboratory abnormalities leading to study treatment discontinuation: 2 sequential neutrophil counts \<750 neutrophils per cubic millimeter (mm\^3); 2 sequential lymphocyte counts \<500 lymphocytes/mm\^3; 2 sequential hemoglobin \<8.0 grams per deciliter; 2 sequential platelet counts \<75000 platelets/mm\^3; 2 sequential AST or ALT elevations \>=3\*ULN with at least one total bilirubin value \>=2\*ULN; 2 sequential AST or ALT elevations \>=3\*ULN accompanied by signs or symptoms consistent with hepatic injury; 2 sequential AST or ALT elevations \>=5\*ULN; 2 sequential increases in creatinine \>50% and \>0.5 milligrams per deciliter over A3921139 baseline; 2 sequential CK elevations \>10\*ULN unless the causality is known not to be medically serious (eg, exercise induced).

Timepoint [21]

Baseline up to 43 months

Secondary outcome [22]

Number of Participants With Vital Sign Abnormalities

Assessment method [22]

Vital signs abnormality criteria included: 1) a) diastolic blood pressure (DBP) of (less than) \<50 millimeter of mercury (mmHg), b) change greater than equal to (\>=) 20 mmHg increase, c) change \>=20 mmHg decrease; 2) a) systolic blood pressure (SBP) of \<90 mmHg, b) change \>=30 mmHg increase, c) change \>=30 mmHg decrease; 3) a) pulse rate value of \<40 beats per minute (bpm), b) pulse rate \>120 bpm. Only those categories in which at least 1 participant had data were reported.

Timepoint [22]

Baseline up to 43 months

Secondary outcome [23]

Number of Participants With Clinically Significant Physical Examinations Abnormalities

Assessment method [23]

Physical examination included assessment of the weight, general appearance, eyes, mouth, lungs, heart, abdomen, musculoskeletal, extremities, skin and lymph nodes. Clinical significance was assessed by the Investigator.

Timepoint [23]

Baseline up to 43 months

Secondary outcome [24]

Number of Participants With Opportunistic Infections, All Malignancy, Gastrointestinal Perforation and Cardiovascular Events Adjudicated by Adjudication Committee

Assessment method [24]

Number of participants with adjudicated opportunistic infections including herpes zoster (non-adjacent or \>2 adjacent dermatomes); all malignancies including non-melanoma skin cancer; gastrointestinal perforation and cardiovascular events including pulmonary embolism and cerebrovascular accident, adjudicated by adjudication committee were reported.

Timepoint [24]

Baseline up to 43 months

Eligibility

Key inclusion criteria

* Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively.
* In stable remission on CP-690,550 10 mg BID
* Agree to use highly effective contraception
* Negative pregnancy test
* Comply with visits, treatments, lab tests, diary and other study procedures
* Signed and dated informed consent document.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease
* Likely to require surgery for ulcerative colitis during study
* Expected to receive any prohibited medication
* Expected to receive live or attenuated virus vaccination during study
* Women who are pregnant or breastfeeding or planning to become pregnant during the study
* Evidence of colonic malignancy or any dysplasia
* Acute or chronic medical or psychiatric condition that may increase risk of participation
* Investigator site staff member
* Subjects likely to be uncooperative or unable to comply with study procedures
* Participation in other studies involving investigational drugs during study
* Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:

* has heart failure;
* has inherited coagulation disorders;
* has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism;
* is taking combined hormonal contraceptives or hormone replacement therapy;
* has malignancy (association is strongest with cancers other than non-melanoma skin cancers);
* is undergoing major surgery

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

16/11/2017

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

18/03/2022

Sample size

Target

Accrual to date

Final

140

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Alabama

Country [2]

United States of America

State/province [2]

California

Country [3]

United States of America

State/province [3]

Connecticut

Country [4]

United States of America

State/province [4]

Florida

Country [5]

United States of America

State/province [5]

Kansas

Country [6]

United States of America

State/province [6]

Maryland

Country [7]

United States of America

State/province [7]

Michigan

Country [8]

United States of America

State/province [8]

New York

Country [9]

United States of America

State/province [9]

Ohio

Country [10]

United States of America

State/province [10]

Texas

Country [11]

United States of America

State/province [11]

Utah

Country [12]

Belgium

State/province [12]

Leuven

Country [13]

Canada

State/province [13]

Ontario

Country [14]

Canada

State/province [14]

Saskatchewan

Country [15]

Czechia

State/province [15]

Strakonice

Country [16]

France

State/province [16]

Nantes

Country [17]

France

State/province [17]

Pessac

Country [18]

Germany

State/province [18]

Kiel

Country [19]

Hungary

State/province [19]

Budapest

Country [20]

Hungary

State/province [20]

Gyula

Country [21]

Italy

State/province [21]

Country [22]

Japan

State/province [22]

Aichi

Country [23]

Japan

State/province [23]

Fukuoka

Country [24]

Japan

State/province [24]

Hokkaido

Country [25]

Japan

State/province [25]

Osaka

Country [26]

Japan

State/province [26]

Shiga

Country [27]

Japan

State/province [27]

Tokyo

Country [28]

Japan

State/province [28]

Chiba

Country [29]

Japan

State/province [29]

Hiroshima

Country [30]

Korea, Republic of

State/province [30]

Gyeonggi-do

Country [31]

Korea, Republic of

State/province [31]

Seoul

Country [32]

Netherlands

State/province [32]

Amsterdam

Country [33]

New Zealand

State/province [33]

Auckland

Country [34]

New Zealand

State/province [34]

Christchurch

Country [35]

New Zealand

State/province [35]

Dunedin

Country [36]

Poland

State/province [36]

Sopot

Country [37]

Poland

State/province [37]

Wroclaw

Country [38]

Russian Federation

State/province [38]

Moscow

Country [39]

Russian Federation

State/province [39]

Novosibirsk

Country [40]

Serbia

State/province [40]

Belgrade

Country [41]

Serbia

State/province [41]

Kragujevac

Country [42]

Serbia

State/province [42]

Zrenjanin

Country [43]

Slovakia

State/province [43]

Bratislava

Country [44]

Slovakia

State/province [44]

Nitra

Country [45]

Slovakia

State/province [45]

Presov

Country [46]

South Africa

State/province [46]

Cape Town

Country [47]

South Africa

State/province [47]

Johannesburg, Gauteng

Country [48]

South Africa

State/province [48]

Johannesburg

Country [49]

South Africa

State/province [49]

Western CAPE

Country [50]

Spain

State/province [50]

Barcelona

Country [51]

Ukraine

State/province [51]

Chernivtsi

Country [52]

Ukraine

State/province [52]

Kyiv

Country [53]

Ukraine

State/province [53]

Uzhgorod

Country [54]

Ukraine

State/province [54]

Vinnytsia

Country [55]

United Kingdom

State/province [55]

Avon

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Pfizer

Country

Ethics approval

Ethics application status

Summary

Brief summary

This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.

Trial website

https://clinicaltrials.gov/study/NCT03281304

Trial related presentations / publications

Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.

Public notes

Contacts

Principal investigator

Name

Pfizer CT.gov Call Center

Address

Pfizer

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		https://cdn.clinicaltrials.gov/large-docs/04/NCT03281304/Prot_001.pdf
Statistical analysis plan		https://cdn.clinicaltrials.gov/large-docs/04/NCT03281304/SAP_000.pdf

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03281304

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03281304