Study of Adalimumab in Patients With Axial Spondyloarthritis

NCT00939003 | Completed Phase 3 Results

• 2 other identifiers: M10-7912009-010643-14
• Study Type: interventional
• Target: 192
• Locations: 10 countries
• Sites: 38

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.

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response

  ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 20 units (on a scale from 0 to 100) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units on a scale from 0 to 100) in the potential remaining domain: * Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe); * Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).

  Baseline and Week 12

Secondary Outcomes (9)

• Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response

  Baseline and Week 12

• Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response

  Baseline and Week 12

• Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score

  Baseline and Week 12

• Number of Participants Achieving ASAS Partial Remission

  Week 12

• Number of Participants Achieving an ASAS5/6 Response

  Baseline and Week 12

Other Outcomes (5)

• Number of Participants Reporting Adverse Events

  Through Week 12

• Number of Participants With Blood Hematology or Chemistry Values Common Toxicity Criteria Grade ≥ 3

  Through Week 12

• Number of Participants Achieving an ASAS20 Response During the Open-label Period

  Baseline and Weeks 52, 104, and 156

Study Arms (3)

Adalimumab

EXPERIMENTAL

Biological: Adalimumab

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Open-label Adalimumab

EXPERIMENTAL

Biological: Open-label Adalimumab

Interventions

Adalimumab BIOLOGICAL

40 mg every other week up to Week 12

Also known as: ABT-D2E7, Humira

Adalimumab

Placebo BIOLOGICAL

Placebo every other week up to Week 12

Placebo

Open-label Adalimumab BIOLOGICAL

40 mg every other week, Week 12 through Week 156

Also known as: ABT-D2E7, Humira

Open-label Adalimumab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (38)

Site Reference ID/Investigator# 21250

Birmingham, Alabama, 35205, United States

Location

Site Reference ID/Investigator# 21249

Colorado Springs, Colorado, 80910, United States

Location

Site Reference ID/Investigator# 21245

Denver, Colorado, 80230, United States

Location

Site Reference ID/Investigator# 21246

Wheaton, Maryland, 20902, United States

Location

Site Reference ID/Investigator# 26582

Duncansville, Pennsylvania, 16635, United States

Location

Site Reference ID/Investigator# 21241

Wyomissing, Pennsylvania, 19610, United States

Location

Site Reference ID/Investigator# 21243

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 21248

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 21247

Seattle, Washington, 98122, United States

Location

Site Reference ID/Investigator# 22342

Brisbane, 4102, Australia

Location

Site Reference ID/Investigator# 21223

Kogarah, 2217, Australia

Location

Site Reference ID/Investigator# 21222

Maroochydore, 4558, Australia

Location

Site Reference ID/Investigator# 21225

Genk, 3600, Belgium

Location

Site Reference ID/Investigator# 21224

Ghent, 9000, Belgium

Location

Site Reference ID/Investigator# 26544

Gilly, 6060, Belgium

Location

Site Reference ID/Investigator# 27382

Merksem, 2170, Belgium

Location

Site Reference ID/Investigator# 21229

Edmonton, T6G 2S2, Canada

Location

Site Reference ID/Investigator# 21226

Sainte-Foy, Quebec, G1W 4R4, Canada

Location

Site Reference ID/Investigator# 21227

St. John's, A1C 5B8, Canada

Location

Site Reference ID/Investigator# 21228

Toronto, M5T 2S8, Canada

Location

Site Reference ID/Investigator# 21231

Brno, 65691, Czechia

Location

Site Reference ID/Investigator# 26882

Pardubice, 530 02, Czechia

Location

Site Reference ID/Investigator# 21230

Prague, 128 50, Czechia

Location

Site Reference ID/Investigator# 26883

Uherské Hradiště, 686 01, Czechia

Location

Site Reference ID/Investigator# 21263

Boulogne-Billancourt, 92100, France

Location

Site Reference ID/Investigator# 21262

Chambray-les-Tour, 37170, France

Location

Site Reference ID/Investigator# 21261

Orléans, 45067, France

Location

Site Reference ID/Investigator# 22343

Paris, 75679, France

Location

Site Reference ID/Investigator# 21266

Berlin, 12200, Germany

Location

Site Reference ID/Investigator# 21267

Erlangen, 91054, Germany

Location

Site Reference ID/Investigator# 21264

Herne, 44652, Germany

Location

Site Reference ID/Investigator# 21265

Munich, 80336, Germany

Location

Site Reference ID/Investigator# 21285

Amsterdam, 1105 AZ, Netherlands

Location

Site Reference ID/Investigator# 21284

Leiden, 2333 ZA, Netherlands

Location

Site Reference ID/Investigator# 21282

A Coruña, 15006, Spain

Location

Site Reference ID/Investigator# 21283

Barcelona, 08907, Spain

Location

Site Reference ID/Investigator# 21281

Córdoba, 14004, Spain

Location

Site Reference ID/Investigator# 21289

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 29587851 DERIVED

• 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.

  PMID: 24574227 DERIVED

• 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.

  PMID: 22772328 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

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 (prior sponsor, Abbott)

800-633-9110

Study Officials

• Aileen L Pangan, MD

  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: July 10, 2009
• First Posted: July 14, 2009
• Study Start: July 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2013
• Last Updated: September 9, 2014
• Results First Posted: March 6, 2012

Record last verified: 2014-09

Locations

CA (4); BE (4); DE (4); FR (4); CZ (4); NL (2); ES (3); AU (3); GB (1); US (9)