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