Phase 2
N=187
A Study Evaluating the Safety and Efficacy of Upadacitinib in Adults With Active Ankylosing Spondylitis
Ankylosing Spondylitis (AS)
Bottom Line
View on ClinicalTrials.gov: NCT03178487 ↗Enrolled (actual)
187
Serious AEs
4.9%
Results posted
Jun 2021
Primary outcome: Primary: Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14 — 25.5; 51.6 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Upadacitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 14 |
25.5; 51.6 | <0.001 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14 |
-0.54; -1.45 | <0.001 sig |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for the Spine at Week 14 |
-0.22; -6.93 | <0.001 sig |
| SECONDARY Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14 |
23.4; 45.2 | 0.002 sig |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score |
-2.67; -4.20 | 0.016 sig |
| SECONDARY Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) Partial Remission |
1.1; 19.4 | <0.001 sig |
| SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14 |
-1.30; -2.29 | 0.001 sig |
| SECONDARY Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMI[Lin]) at Week 14 |
-0.14; -0.37 | 0.030 sig |
| SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 14 |
-1.41; -2.25 | 0.049 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment at Week 14 |
-12.60; -18.11 | 0.190 |
| SECONDARY Change From Baseline in ASAS Health Index (HI) at Week 14 |
-1.38; -2.75 | 0.007 sig |
| SECONDARY Percentage of Participants Achieving an ASAS 20 Response at Week 14 |
40.4; 64.5 | 0.001 sig |
| SECONDARY Change From Baseline in SPARCC MRI Score for Sacroiliac Joints at Week 14 |
-0.22; -3.91 | <0.001 sig |
Summary
The purpose of this study is to evaluate the safety and efficacy of upadacitinib in participants with active ankylosing spondylitis (AS) who have had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
Eligibility Criteria
Inclusion Criteria
- Participant with a clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York criteria for AS.
- Participant must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4 and a Patient's Assessment of Total Back Pain score >= 4 based on a 0 - 10 numeric rating scale (NRS) at the Screening and Baseline visits.
- Participant has had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs as defined by the Investigator.
- If entering the study on concomitant methotrexate (MTX), leflunomide, sulfasalazine (SSZ), and/or hydroxychloroquine, participant must be on a stable dose of MTX ( 2 × upper limit of normal (ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease formula < 40 milliliter (mL)/minute/1.73m^2; hemoglobin < 10 gram/deciliter, total white blood cell count < 2,500/microliter (μL); absolute neutrophil count < 1,500/μL; absolute lymphocyte count < 800/μL; and platelet count < 100,000/μL.
Data sourced from ClinicalTrials.gov (NCT03178487). 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.