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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03502616




Registration number
NCT03502616
Ethics application status
Date submitted
11/04/2018
Date registered
18/04/2018
Date last updated
17/09/2021

Titles & IDs
Public title
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Scientific title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)
Secondary ID [1] 0 0
AS
Secondary ID [2] 0 0
A3921120
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib

Experimental: Tofacitinib -

Placebo Comparator: Placebo -


Treatment: Drugs: Tofacitinib
Oral administration twice per day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants Achieving Ankylosing Spondylitis (ASAS)40 Response at Week 16
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs)
Timepoint [2] 0 0
Baseline up to Week 16 and Baseline up to Week 48
Secondary outcome [3] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity
Timepoint [3] 0 0
Baseline up to Week 16 and Baseline up to Week 48
Secondary outcome [4] 0 0
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Timepoint [4] 0 0
Baseline up to Week 16 and Baseline up to Week 48
Secondary outcome [5] 0 0
Number of Participants With Vital Signs Abnormalities
Timepoint [5] 0 0
Baseline up to Week 16 and Baseline up to Week 48
Secondary outcome [6] 0 0
Number of Participants With Abnormalities in Physical Examination
Timepoint [6] 0 0
Screening, Week 16, and Week 48
Secondary outcome [7] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities
Timepoint [7] 0 0
Baseline up to Week 16, Baseline up to Week 48
Secondary outcome [8] 0 0
Percentage of Participants Achieving ASAS20 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Timepoint [8] 0 0
Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Secondary outcome [9] 0 0
Percentage of Participants Achieving ASAS40 Response at Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Timepoint [9] 0 0
Weeks 2, 4, 8, 12, 24, 32, 40 and 48
Secondary outcome [10] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [10] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [11] 0 0
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [11] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [12] 0 0
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at Weeks 16 and 48
Timepoint [12] 0 0
Baseline, Weeks 16 and 48
Secondary outcome [13] 0 0
Change From Baseline in Short-Form-36 Health Survey-Version 2 Acute (SF-36v2) Score at Weeks 16 and 48
Timepoint [13] 0 0
Baseline, Weeks 16 and 48
Secondary outcome [14] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Cervical Rotation Angle at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [14] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [15] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Intermalleolar Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [15] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [16] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lateral Spinal Flexion at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [16] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [17] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Lumbar Flexion (Modified Schober) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [17] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [18] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Scores: Tragus-to-wall Distance at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [18] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [19] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) Linear Method Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [19] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [20] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [20] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [21] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [21] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [22] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Scores at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [22] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [23] 0 0
Change From Baseline in Patient's Global Assessment of Disease (PGA) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [23] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [24] 0 0
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [24] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [25] 0 0
Change From Baseline in Patient's Assessment of Spinal Pain: Nocturnal Spinal Pain at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [25] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [26] 0 0
Change From Baseline in in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [26] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [27] 0 0
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Inflammation (Morning Stiffness) Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [27] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [28] 0 0
Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [28] 0 0
Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [29] 0 0
Percentage of Participants Achieving ASAS Partial Remission at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [29] 0 0
Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [30] 0 0
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [30] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [31] 0 0
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [31] 0 0
Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [32] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Clinically Important Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [32] 0 0
Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [33] 0 0
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Major Improvement Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [33] 0 0
Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [34] 0 0
Percentage of Participants Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein (ASDAS[CRP]) Inactive Disease Response at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [34] 0 0
Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [35] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [35] 0 0
Baseline, Weeks 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [36] 0 0
Change From Baseline in Swollen Joint Count (SJC) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [36] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [37] 0 0
Change From Baseline in Spinal Mobility (Chest Expansion ) at Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Timepoint [37] 0 0
Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48
Secondary outcome [38] 0 0
Change From Baseline in EuroQol 5 Dimensions 3 Levels (EQ-5D-3L) Score at Weeks 16 and 48
Timepoint [38] 0 0
Baseline, Weeks 16 and 48
Secondary outcome [39] 0 0
Change From Baseline in EuroQol Visual Analogue Scale (EQ-VAS) Score (mm) at Weeks 16 and 48
Timepoint [39] 0 0
Baseline, Weeks 16 and 48
Secondary outcome [40] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed Due to Health Problem at Weeks 16 and 48
Timepoint [40] 0 0
Baseline, Weeks 16 and 48
Secondary outcome [41] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working Due to Health Problem at Weeks 16 and 48
Timepoint [41] 0 0
Baseline, Weeks 16 and 48
Secondary outcome [42] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health Problem at Weeks 16 and 48
Timepoint [42] 0 0
Baseline, Weeks 16 and 48
Secondary outcome [43] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment Due to Health Problem at Weeks 16 and 48
Timepoint [43] 0 0
Baseline, Weeks 16 and 48

Eligibility
Key inclusion criteria
- Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria
for AS (1984).

- Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.

- Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or
intolerant to NSAIDs.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- History of known or suspected complete ankylosis of the spine.

- History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.

- History of any other rheumatic disease.

- Any subject with condition affecting oral drug absorption.

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/08/2020
Sample size
Target
Accrual to date
Final
270
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Pacific Radiology, - Maroochydore
Recruitment hospital [2] 0 0
Rheumatology Research Unit Sunshine Coast - Maroochydore
Recruitment hospital [3] 0 0
Emeritus Research Pty. Ltd. - Camberwell
Recruitment hospital [4] 0 0
Melbourne Radiology Clinic - East Melbourne
Recruitment hospital [5] 0 0
SKG Radiology - Subiaco
Recruitment hospital [6] 0 0
Western Cardiology - Subiaco
Recruitment hospital [7] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
3124 - Camberwell
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Plovdiv
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sofia
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Zhejiang
Country [20] 0 0
China
State/province [20] 0 0
Shanghai
Country [21] 0 0
Czechia
State/province [21] 0 0
Ostrava
Country [22] 0 0
Czechia
State/province [22] 0 0
Pardubice
Country [23] 0 0
Czechia
State/province [23] 0 0
Uherske Hradiste
Country [24] 0 0
France
State/province [24] 0 0
TOURS Cedex 9
Country [25] 0 0
Hungary
State/province [25] 0 0
Budapest
Country [26] 0 0
Hungary
State/province [26] 0 0
Kistarcsa
Country [27] 0 0
Hungary
State/province [27] 0 0
Veszprém
Country [28] 0 0
Israel
State/province [28] 0 0
Ashkelon
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Gwangju
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Incheon
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Poland
State/province [32] 0 0
Katowice
Country [33] 0 0
Poland
State/province [33] 0 0
Krakow
Country [34] 0 0
Poland
State/province [34] 0 0
Lublin
Country [35] 0 0
Poland
State/province [35] 0 0
Poznan
Country [36] 0 0
Poland
State/province [36] 0 0
Sochaczew
Country [37] 0 0
Poland
State/province [37] 0 0
Warszawa
Country [38] 0 0
Poland
State/province [38] 0 0
Wroclaw
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Kemerovo
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Orenburg
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Saint-Petersburg
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Saratov
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Smolensk
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Vladimir
Country [45] 0 0
Turkey
State/province [45] 0 0
Ankara
Country [46] 0 0
Turkey
State/province [46] 0 0
Istanbul
Country [47] 0 0
Turkey
State/province [47] 0 0
Izmir
Country [48] 0 0
Ukraine
State/province [48] 0 0
Kyiv
Country [49] 0 0
Ukraine
State/province [49] 0 0
Lviv
Country [50] 0 0
Ukraine
State/province [50] 0 0
Ternopil
Country [51] 0 0
Ukraine
State/province [51] 0 0
Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if tofacitinib is safe and effective in subjects
with active ankylosing spondylitis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03502616
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries