Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01786668
• Date of registration: 06/02/2013
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis
• Scientific title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)
• Date of first enrolment: April 2013
• Target sample size: 208
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01786668
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, Czech Republic, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Spain, Taiwan, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Documented diagnosis of Ankylosing Spondylitis

- Has active disease despite concurrent nonsteroidal anti-inflammatory drugs (NSAIDs)
treatment or is intolerant to NSAIDs

Exclusion Criteria:

- Pregnant or lactating females

- Currently receiving or previous use of a Tumor Necrosis Factor (TNF) inhibitor or any
biological agent



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

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Placebo

Drug: Tofacitinib 5 mg

Drug: Tofacitinib 10 mg

Drug: Tofacitinib 2 mg

Primary Outcome(s)

Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12 [Time Frame: Week 12]

Percentage of Participants Achieving ASAS20 at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12 [Time Frame: Baseline, Week 12]

Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History [Time Frame: Baseline, Week 12 and Follow-up]

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12 [Time Frame: Baseline, Week 12]

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12 [Time Frame: Baseline, Week 4, Week 8, Week 12]

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12 [Time Frame: Baseline, Week 12]

Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12 [Time Frame: Baseline, Week 12]

Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8 [Time Frame: Baseline, Week 2, Week 4, Week 8]

Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12 [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 12]

Secondary ID(s)

2011-005689-39

A3921119

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/06/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01786668