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Study of Adalimumab in Patients With Axial Spondyloarthritis

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Axial Spondyloarthritis

Intervention: Adalimumab (Biological); Placebo (Biological); Open-label Adalimumab (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Aileen L Pangan, MD, Study Director, Affiliation: AbbVie


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.

Clinical Details

Official title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response

Secondary outcome:

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

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

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

Number of Participants Achieving ASAS Partial Remission

Number of Participants Achieving an ASAS5/6 Response

Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)

Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints

Change From Baseline in SPARCC MRI Score for the Spine

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).


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Locations and Contacts

Site Reference ID/Investigator# 22342, Brisbane 4102, Australia

Site Reference ID/Investigator# 21223, Kogarah 2217, Australia

Site Reference ID/Investigator# 21222, Maroochydore 4558, Australia

Site Reference ID/Investigator# 21225, Genk 3600, Belgium

Site Reference ID/Investigator# 21224, Ghent 9000, Belgium

Site Reference ID/Investigator# 26544, Gilly 6060, Belgium

Site Reference ID/Investigator# 27382, Merksem 2170, Belgium

Site Reference ID/Investigator# 21229, Edmonton T6G 2S2, Canada

Site Reference ID/Investigator# 21226, Sainte-Foy, Quebec G1W 4R4, Canada

Site Reference ID/Investigator# 21227, St. John's A1C 5B8, Canada

Site Reference ID/Investigator# 21228, Toronto M5T 2S8, Canada

Site Reference ID/Investigator# 21231, Brno 65691, Czech Republic

Site Reference ID/Investigator# 26882, Pardubice 530 02, Czech Republic

Site Reference ID/Investigator# 21230, Prague 2 128 50, Czech Republic

Site Reference ID/Investigator# 26883, Uherske Hradiste 686 01, Czech Republic

Site Reference ID/Investigator# 21263, Boulogne Billancourt 92100, France

Site Reference ID/Investigator# 21262, Chambray-les-Tour 37170, France

Site Reference ID/Investigator# 21261, Orleans 45067, France

Site Reference ID/Investigator# 22343, Paris Cedex 14 75679, France

Site Reference ID/Investigator# 21266, Berlin 12200, Germany

Site Reference ID/Investigator# 21267, Erlangen 91054, Germany

Site Reference ID/Investigator# 21264, Herne 44652, Germany

Site Reference ID/Investigator# 21265, Munich 80336, Germany

Site Reference ID/Investigator# 21285, Amsterdam 1105 AZ, Netherlands

Site Reference ID/Investigator# 21284, Leiden 2333 ZA, Netherlands

Site Reference ID/Investigator# 21282, A Coruna 15006, Spain

Site Reference ID/Investigator# 21283, Barcelona 08907, Spain

Site Reference ID/Investigator# 21281, Cordoba 14004, Spain

Site Reference ID/Investigator# 21289, Newcastle upon Tyne NE7 7DN, United Kingdom

Site Reference ID/Investigator# 21250, Birmingham, Alabama 35205, United States

Site Reference ID/Investigator# 21249, Colorado Springs, Colorado 80910, United States

Site Reference ID/Investigator# 21245, Denver, Colorado 80230, United States

Site Reference ID/Investigator# 21246, Wheaton, Maryland 20902, United States

Site Reference ID/Investigator# 26582, Duncansville, Pennsylvania 16635, United States

Site Reference ID/Investigator# 21241, Wyomissing, Pennsylvania 19610, United States

Site Reference ID/Investigator# 21243, Dallas, Texas 75231, United States

Site Reference ID/Investigator# 21248, Houston, Texas 77030, United States

Site Reference ID/Investigator# 21247, Seattle, Washington 98122, United States

Additional Information

Starting date: July 2009
Last updated: September 4, 2014

Page last updated: August 23, 2015

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