Status:
COMPLETED
Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
Lead Sponsor:
AbbVie
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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 ma...
Detailed Description
The study duration included a 42-day Screening Period, a 28-week open-label 40 mg adalimumab every other week (eow) treatment period (Period 1), a 40-week double-blind placebo controlled eow treatment...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2017
Estimated Enrollment :
673 Patients enrolled
Trial Details
Trial ID
NCT01808118
Start Date
April 16 2013
End Date
April 14 2017
Last Update
May 30 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.