Study of Adalimumab in Patients With Axial Spondyloarthritis

NCT ID: NCT00939003

Last Updated: 2014-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-08-31

Brief Summary

This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

Detailed Description

This is a Phase 3, placebo-controlled, double-blind randomized study with an open-label phase designed to evaluate the efficacy and safety of adalimumab 40 mg administered every other week in adult patients with active axial spondyloarthritis (SpA) who are not diagnosed with ankylosing spondylitis, psoriasis, or psoriatic arthritis and who have had an inadequate response or intolerance to one or more nonsteroidal anti-inflammatory drugs (NSAIDs) or had a contraindication to NSAIDs. Participants receive adalimumab or placebo for 12 weeks during the double-blind phase of the study. Following the double-blind phase, all remaining participants enter the open-label phase of the study in which they receive open-label adalimumab for up to 144 weeks. Efficacy endpoints include the Assessment of Spondyloarthritis International Society (ASAS) response criteria for patients with SpA. These response criteria were used to determine participants who were responders. ASAS response involves evaluations in the following 4 domains: participant's global assessment of disease activity, pain, function, and inflammation. The patient's global assessment of disease activity score is assessed using a 100 millimeter (mm) visual analog scale (VAS; 0 for no disease activity to 100 for severe disease activity). Pain is represented as a total back pain score and is assessed using a 100 mm VAS (0 for no pain to 100 for most severe pain). Function score is represented as the Bath Ankylosing Spondylitis (AS) Functional Index (BASFI) 100 mm VAS score (average of the ability to perform 10 activities, each scored as 0 for easy to 100 for impossible). Inflammation is determined using the morning stiffness overall level score (0 for none to 10 for very severe) and duration score (0 for 0 hours to 10 for ≥ 2 hours) of the Bath AS Disease Activity Index (BASDAI) (mean of these items #5 and #6 scores). In addition, the BASDAI is used as an efficacy endpoint. The BASDAI is used by the participant to assess his/her disease activity. Using VAS scales, the participant answers 6 questions pertaining to symptoms experienced over the past week. For 5 questions (levels of: fatigue/tiredness; AS neck, back, or hip pain; pain/swelling; discomfort at areas tender to touch or pressure; and morning stiffness), the response scale is 0 (none) to 10 (very severe). For 1 question (duration of morning stiffness), the response scale is 0 (0 hours) to 10 (≥ 2 or more hours).

Conditions

Axial Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Adalimumab

Group Type: EXPERIMENTAL

Adalimumab

Intervention Type: BIOLOGICAL

40 mg every other week up to Week 12

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo every other week up to Week 12

Open-label Adalimumab

Group Type: EXPERIMENTAL

Open-label Adalimumab

Intervention Type: BIOLOGICAL

40 mg every other week, Week 12 through Week 156

Interventions

Adalimumab

40 mg every other week up to Week 12

Intervention Type: BIOLOGICAL

Placebo

Placebo every other week up to Week 12

Intervention Type: BIOLOGICAL

Open-label Adalimumab

40 mg every other week, Week 12 through Week 156

Intervention Type: BIOLOGICAL

Other Intervention Names

ABT-D2E7; Humira; ABT-D2E7; Humira

Eligibility Criteria

Inclusion Criteria

• Adult patients with inadequate response to >/= 1 non-steroidal anti-inflammatory drugs (NSAIDs)
• Chronic back pain with onset < 45 years of age
• Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria
• Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative
• Ability to administer subcutaneous injections
• General good health otherwise

Exclusion Criteria

• Prior anti-tumor necrosis factor (TNF) therapy
• Psoriasis or psoriatic arthritis
• Fulfillment of modified New York criteria for ankylosing spondylitis
• Recent infection requiring treatment
• Significant medical events or conditions that may put patients at risk for participation
• Females who are pregnant or breast-feeding or considering becoming pregnant during the study
• History of cancer, except successfully treated skin cancer
• Recent history of drug or alcohol abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aileen L Pangan, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 21250

Birmingham, Alabama, United States

Site Reference ID/Investigator# 21249

Colorado Springs, Colorado, United States

Site Reference ID/Investigator# 21245

Denver, Colorado, United States

Site Reference ID/Investigator# 21246

Wheaton, Maryland, United States

Site Reference ID/Investigator# 26582

Duncansville, Pennsylvania, United States

Site Reference ID/Investigator# 21241

Wyomissing, Pennsylvania, United States

Site Reference ID/Investigator# 21243

Dallas, Texas, United States

Site Reference ID/Investigator# 21248

Houston, Texas, United States

Site Reference ID/Investigator# 21247

Seattle, Washington, United States

Site Reference ID/Investigator# 22342

Brisbane, , Australia

Site Reference ID/Investigator# 21223

Kogarah, , Australia

Site Reference ID/Investigator# 21222

Maroochydore, , Australia

Site Reference ID/Investigator# 21225

Genk, , Belgium

Site Reference ID/Investigator# 21224

Ghent, , Belgium

Site Reference ID/Investigator# 26544

Gilly, , Belgium

Site Reference ID/Investigator# 27382

Merksem, , Belgium

Site Reference ID/Investigator# 21229

Edmonton, , Canada

Site Reference ID/Investigator# 21226

Sainte-Foy, Quebec, , Canada

Site Reference ID/Investigator# 21227

St. John's, , Canada

Site Reference ID/Investigator# 21228

Toronto, , Canada

Site Reference ID/Investigator# 21231

Brno, , Czechia

Site Reference ID/Investigator# 26882

Pardubice, , Czechia

Site Reference ID/Investigator# 21230

Prague, , Czechia

Site Reference ID/Investigator# 26883

Uherské Hradiště, , Czechia

Site Reference ID/Investigator# 21263

Boulogne-Billancourt, , France

Site Reference ID/Investigator# 21262

Chambray-les-Tour, , France

Site Reference ID/Investigator# 21261

Orléans, , France

Site Reference ID/Investigator# 22343

Paris, , France

Site Reference ID/Investigator# 21266

Berlin, , Germany

Site Reference ID/Investigator# 21267

Erlangen, , Germany

Site Reference ID/Investigator# 21264

Herne, , Germany

Site Reference ID/Investigator# 21265

Munich, , Germany

Site Reference ID/Investigator# 21285

Amsterdam, , Netherlands

Site Reference ID/Investigator# 21284

Leiden, , Netherlands

Site Reference ID/Investigator# 21282

A Coruña, , Spain

Site Reference ID/Investigator# 21283

Barcelona, , Spain

Site Reference ID/Investigator# 21281

Córdoba, , Spain

Site Reference ID/Investigator# 21289

Newcastle upon Tyne, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Czechia; France; Germany; Netherlands; Spain; United Kingdom

References

van der Heijde D, Sieper J, Maksymowych WP, Lambert RG, Chen S, Hojnik M, Anderson JK, Pangan AL. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial. Arthritis Res Ther. 2018 Mar 27;20(1):61. doi: 10.1186/s13075-018-1556-5.

Reference Type: DERIVED

PMID: 29587851 (View on PubMed)

van der Heijde D, Sieper J, Maksymowych WP, Brown MA, Lambert RG, Rathmann SS, Pangan AL. Spinal inflammation in the absence of sacroiliac joint inflammation on magnetic resonance imaging in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2014 Mar;66(3):667-73. doi: 10.1002/art.38283.

Reference Type: DERIVED

PMID: 24574227 (View on PubMed)

Sieper J, van der Heijde D, Dougados M, Mease PJ, Maksymowych WP, Brown MA, Arora V, Pangan AL. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013 Jun;72(6):815-22. doi: 10.1136/annrheumdis-2012-201766. Epub 2012 Jul 7.

Reference Type: DERIVED

PMID: 22772328 (View on PubMed)

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

2009-010643-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-791

Identifier Type: -

Identifier Source: org_study_id