Phase 2 N=207 Randomized Quadruple-blind Treatment

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

Ankylosing Spondylitis

Bottom Line

View on ClinicalTrials.gov: NCT01786668 ↗

Enrolled (actual)

207

Serious AEs

1.9%

Results posted

Jun 2016

Primary outcome: Primary: Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12 — 56.0; 63.0; 67.4; 40.1 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tofacitinib 2 mg (Drug); Tofacitinib 5 mg (Drug); Tofacitinib 10 mg (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12	56.0; 63.0; 67.4; 40.1	—
PRIMARY Percentage of Participants Achieving ASAS20 at Week 12	51.92; 80.77; 55.77; 41.18	0.271
SECONDARY Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8	40.38; 32.69; 34.62; 27.45; 48.08; 55.77	0.162
SECONDARY 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	-1.70; -3.15; -3.55; -0.81	0.427
SECONDARY Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12	-3.09; -5.51; -6.57; -0.09	0.050
SECONDARY Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12	-1.05; -2.22; -2.13; -0.41	0.221
SECONDARY Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12	13.46; 13.46; 17.31; 15.69; 28.85; 32.69	0.749
SECONDARY Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12	23.08; 13.46; 21.15; 7.84; 19.23; 30.77	0.028 sig
SECONDARY Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12	-0.68; -1.00; -0.97; -0.50; -1.01; -1.20	0.175
SECONDARY Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12	26.92; 48.08; 40.38; 15.69; 42.31; 57.69	0.159
SECONDARY Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12	7.69; 7.69; 7.69; 1.96; 11.54; 11.54	0.170
SECONDARY Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12	1.92; 1.92; 1.92; 0.00; 1.92; 5.77	0.313
SECONDARY Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12	-1.45; -1.53; -1.24; -1.42; -1.90; -1.93	0.926
SECONDARY Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12	11.54; 21.15; 13.46; 15.69; 28.85; 23.08	0.539
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12	-1.12; -1.16; -0.86; -0.74; -1.36; -1.61	0.164
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12	-0.09; -0.24; -0.22; -0.09; -0.15; -0.24	0.982
SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12	-0.16; -0.93; -0.89; -0.11; -0.79; -1.19	0.895
SECONDARY Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History	100; 88.9; 100; 100; 0; 0	—
SECONDARY Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12	-0.53; 0.23; -1.20; -0.43; -0.87; -0.57	0.800
SECONDARY Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12	0.30; 0.35; -0.03; 0.24; 0.54; 0.13	0.785
SECONDARY Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12	6.34; 6.49; 7.05; 2.69; 2.08; 4.15	0.006 sig
SECONDARY Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12	0.17; 0.16; 0.22; 0.10	0.125
SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12	3.62; 1.97; 2.17; 1.90; 4.25; 3.67	0.163

Summary

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01786668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.