Phase 3
N=673
Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
Axial Spondyloarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01808118 ↗Enrolled (actual)
673
Serious AEs
3.5%
Results posted
Apr 2018
Primary outcome: Primary: Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68 — 72; 107 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adalimumab (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68 |
72; 107 | <0.001 sig |
| SECONDARY Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at 12 Weeks After Initiation of Rescue Therapy |
37; 20 | — |
| SECONDARY Number of Participants Achieving ASDAS Major Improvement at 12 Weeks After Initiation of Rescue Therapy |
21; 8 | — |
| SECONDARY Number of Participants Achieving ASDAS Clinically Important Improvement at 12 Weeks After Initiation of Rescue Therapy |
37; 17 | — |
| SECONDARY Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at 12 Weeks After Initiation of Rescue Therapy |
46; 19 | — |
| SECONDARY Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at 12 Weeks After Initiation of Rescue Therapy |
35; 16 | — |
| SECONDARY Number of Participants Achieving an ASAS 5/6 Response at 12 Weeks After Initiation of Rescue Therapy |
25; 9 | — |
| SECONDARY Number of Participants Achieving ASAS Partial Remission at 12 Weeks After Initiation of Rescue Therapy |
26; 15 | — |
| SECONDARY Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at 12 Weeks After Initiation of Rescue Therapy |
41; 18 | — |
| SECONDARY Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at 12 Weeks After Initiation of Rescue Therapy |
-0.3; -0.4 | — |
| SECONDARY Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at Weeks 28 and 68 |
295; 51; 87 | — |
| SECONDARY Number of Participants Achieving ASDAS Major Improvement at Weeks 28 and 68 |
266; 49; 89 | — |
| SECONDARY Number of Participants Achieving ASDAS Clinically Important Improvement at Weeks 28 and 68 |
316; 69; 102 | — |
| SECONDARY Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Weeks 28 and 68 |
315; 72; 107 | — |
| SECONDARY Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Weeks 28 and 68 |
302; 70; 100 | — |
| SECONDARY Number of Participants Achieving an ASAS 5/6 Response at Weeks 28 and 68 |
253; 49; 87 | — |
| SECONDARY Number of Participants Achieving ASAS Partial Remission at Weeks 28 and 68 |
224; 41; 64 | — |
| SECONDARY Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Weeks 28 and 68 |
317; 72; 103 | — |
| SECONDARY Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at Weeks 28 and 68 |
-0.8; -0.8; -0.8 | — |
| SECONDARY Time to Flare at Week 68 |
NA; NA | <0.001 sig |
| SECONDARY Time to Partial Flare at Week 68 |
41; 42 | — |
| SECONDARY Number of Participants Reaching Flare Definition by Week 68 |
81; 45 | — |
| SECONDARY Number of Participants Reaching Partial Flare Definition by Week 68 |
98; 62 | — |
Summary
The objective of this multicenter, randomized, double-blind study was to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week SC in maintaining remission in subjects with moderate to severe non-radiographic axial spondyloarthritis.
Eligibility Criteria
Inclusion Criteria
- Adult participants with inadequate response to ≥2 nonsteroidal anti-inflammatory drugs (NSAIDs)
- Participants with non-radiographic axial spondyloarthritis fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axial SpA classification criteria, but not fulfilling the radiologic criterion of the modified New York criteria for ankylosing spondylitis
- Participants must have baseline disease activity as defined by having an Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥ 2.100, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 and Patient's Assessment of Total Back Pain score ≥ 4 based on a Numeric Rating Scale (NRS) at both the screening and baseline visits
- Participants with evidence of active inflammation in the sacroiliac (SI) joints or spine on MRI, or elevated high sensitivity C-reactive protein (hs-CRP) at screening
- Negative tuberculosis (TB) screening assessment
- Ability to administer subcutaneous injections or have a qualified person available to administer injections
- If female, either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or of childbearing potential and practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug.
- Participant judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray, and a 12-lead electrocardiogram performed at screening
Exclusion Criteria
- Prior anti-Tumor Necrosis Factor (TNF) therapy; biologic therapy with a potential therapeutic impact on SpA or treated with an investigational drug of chemical or biologic nature within 30 days or 5 half-lives prior to the baseline visit.
- Fulfillment of the radiologic criterion of the modified New York criteria for Ankylosing Spondylitis at or prior to the screening visit
- Recent infection requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the baseline visit
- Significant medical events or conditions that may put participants at risk for participation
- Female participants who are pregnant or breast-feeding or considering becoming pregnant during the study
- Known hypersensitivity to adalimumab or its excipients as stated in the label
Data sourced from ClinicalTrials.gov (NCT01808118). 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.