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

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ClinicalTrials.gov Identifier: NCT03502616
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Tofacitinib Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : August 2, 2020
Estimated Study Completion Date : August 2, 2020


Arm Intervention/treatment
Experimental: Tofacitinib Drug: Tofacitinib
Oral administration twice per day

Placebo Comparator: Placebo Drug: Tofacitinib
Oral administration twice per day




Primary Outcome Measures :
  1. Assessment in Ankylosing Spondylitis (ASAS) 20 response [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Assessment in Ankylosing Spondylitis (ASAS) 40 response [ Time Frame: Weeks 2,4, 8, 12, 16, 24, 32, 40 and 48 ]
  2. Assessment in Ankylosing Spondylitis (ASAS) 20 response [ Time Frame: Weeks 2, 4, 8, 12, 24, 32, 40 and 48 ]
  3. 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 ]
  4. Change from baseline in high sensitivity C-reactive protein [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  5. 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 ]
  6. Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  7. BASDAI50 response [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  8. Change from baseline in Bath Ankylosing Spondylitis Functional Index [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  9. 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 ]
    5 components are Lateral Spinal Flexion, Tragus to wall distance, Lumbar flexion, Maximal Intermalleolar distance and Cervical Rotation

  10. Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  11. 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 ]
  12. Change from baseline in Spinal Mobility: Chest Expansion [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
    Chest expansion is measured as the difference between maximal inspiration and expiration

  13. ASAS partial remission response at all time points [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  14. Incidence and severity of Adverse Events [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  15. Change from baseline in EuroQol EQ-5D Health State Profile 3 level and Your own health state today [ Time Frame: Weeks 16 and 48 ]
  16. Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
    3-endpoints: total score, experience domain and impact domain scores

  17. Change from baseline in Ankylosing Spondylitis Quality of Life [ Time Frame: Weeks 2, 4, 12, 16, 24, 32, 40 and 48 ]
  18. Change from baseline in Work Productivity and Activity Impairment Questionnaire Spondyloarthritis [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  19. 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 ]
  20. Change from baseline in Patients Global Assessment of Disease [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]
  21. 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 ]
  22. 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 ]
  23. ASAS 5/6 response [ Time Frame: Weeks 2, 4, 8, 12, 16, 24, 32, 40 and 48 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03502616


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 89 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03502616     History of Changes
Other Study ID Numbers: A3921120
AS ( Other Identifier: Alias Study Number )
2018-000226-58 ( EudraCT Number )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action