Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis

NCT01808118 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: M13-3752012-000646-35
• Study Type: interventional
• Target: 673
• Locations: 0 countries
• Sites: N/A

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 maintaining remission in subjects with moderate to severe non-radiographic axial spondyloarthritis.

Conditions

Axial Spondyloarthritis

Keywords

Spondylitis; Spondylarthropathy; Ankylosing Spondyloarthritis; Spondyloarthritis; Spinal Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Adalimumab; Antirheumatic Agents; Anti-Inflammatory Agents

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68

  The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.

  From Week 28 through 68

Secondary Outcomes (22)

• Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at 12 Weeks After Initiation of Rescue Therapy

  Rescue Therapy Week 12

• Number of Participants Achieving ASDAS Major Improvement at 12 Weeks After Initiation of Rescue Therapy

  Baseline and Rescue Therapy Week 12

• Number of Participants Achieving ASDAS Clinically Important Improvement at 12 Weeks After Initiation of Rescue Therapy

  Baseline and Rescue Therapy Week 12

• Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at 12 Weeks After Initiation of Rescue Therapy

  Baseline and Rescue Therapy Week 12

• Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at 12 Weeks After Initiation of Rescue Therapy

  Baseline and Rescue Therapy Week 12

Study Arms (3)

Double-Blind Adalimumab

EXPERIMENTAL

40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare.

Biological: adalimumab

Open-label (OL) Adalimumab

EXPERIMENTAL

40 mg every other week (eow), Weeks 0-28. If participants flared during the double-blind period, they had an opportunity to receive at least 12 weeks of open-label adalimumab 40 mg eow.

Biological: adalimumab

Placebo

PLACEBO COMPARATOR

Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare.

Biological: Placebo

Interventions

adalimumab BIOLOGICAL

40 mg every other week

Also known as: Humira, ABT-D2E7

Double-Blind Adalimumab; Open-label (OL) Adalimumab

Placebo BIOLOGICAL

every other week

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• Landewe R, Sieper J, Mease P, Inman RD, Lambert RG, Deodhar A, Marzo-Ortega H, Magrey M, Kiltz U, Wang X, Li M, Zhong S, Mostafa NM, Lertratanakul A, Pangan AL, Anderson JK. Efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with non-radiographic axial spondyloarthritis (ABILITY-3): a multicentre, randomised, double-blind study. Lancet. 2018 Jul 14;392(10142):134-144. doi: 10.1016/S0140-6736(18)31362-X. Epub 2018 Jun 29.

  PMID: 29961640 DERIVED

Related Links

• Humira Prescribing Information

MeSH Terms

Conditions

Axial Spondyloarthritis; Spondylitis; Spondylarthropathies; Spondylitis, Ankylosing; Spondylarthritis; Spinal Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Bone Diseases; Ankylosis; Bone Diseases, Infectious; Infections

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: March 11, 2013
• Study Start: April 16, 2013
• Primary Completion: February 21, 2017
• Study Completion: April 14, 2017
• Last Updated: May 30, 2018
• Results First Posted: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share