Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03502616
• Date of registration: 11/04/2018
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• 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)
• Date of first enrolment: June 7, 2018
• Target sample size: 270
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03502616
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Bulgaria, Canada, China, Czechia, France, Hungary, Israel, Korea, Republic of, Poland, Russian Federation, Slovakia, Spain, Taiwan, Turkey, Ukraine, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Tofacitinib

Primary Outcome(s)

Assessment in Ankylosing Spondylitis (ASAS) 20 response [Time Frame: Week 16]

Secondary Outcome(s)

BASDAI50 response [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from Baseline in Ankylosing Spondylitis Disease Activity Score using C-Reactive Protein [Time Frame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Short-Form-36-Health Survey Version 2 Acute [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Spinal Mobility: Chest Expansion [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Work Productivity and Activity Impairment Questionnaire Spondyloarthritis [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Bath Ankylosing Spondylitis Functional Index [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in extra-articular involvement (Specific Medical History and peripheral articular involvement [as assessed by change from baseline in swollen joint count (44)]) [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Assessment in Ankylosing Spondylitis (ASAS) 40 response [Time Frame: Weeks 2,4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in EuroQol EQ-5D Health State Profile 3 level and Your own health state today [Time Frame: Weeks 16 and 48]

Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement, ASDAS major improvement and ASDAS inactive disease [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Bath Ankylosing Spondylitis Metrology Index and its 5 components [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Assessment in Ankylosing Spondylitis (ASAS) 20 response [Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40 and 48]

Change from baseline in inflammation (mean of the answers to questions 5 and 6 of the BASDAI) [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in high sensitivity C-reactive protein [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Incidence and severity of Adverse Events [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

ASAS 5/6 response [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Patients Global Assessment of Disease [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

ASAS partial remission response at all time points [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Change from baseline in Ankylosing Spondylitis Quality of Life [Time Frame: Weeks 2, 4, 12, 16, 24, 32, 40 and 48]

Change from baseline in Patient's Assessment of Spinal Pain (Total Back Pain, Nocturnal Spinal Pain) [Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48]

Secondary ID(s)

AS

2018-000226-58

A3921120

Source(s) of Monetary Support

Please refer to primary and secondary sponsors