Study of Adalimumab in Subjects With Axial Spondyloarthritis - Full Text View

Sponsor:	Abbott
Information provided by (Responsible Party):	Abbott
ClinicalTrials.gov Identifier:	NCT00939003

Purpose

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

Condition	Intervention	Phase
Axial Spondyloarthritis	Biological: Adalimumab Biological: Placebo Biological: Open-label Adalimumab	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis

Resource links provided by NLM:

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Number of Participants Achieving ASAS40 Response (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ASAS40 response is improvement of >/=40% and absolute improvement of >/=20 units (scale of 0-100) in >/= 3 of 4 domains, plus absence of any deterioration (net worsening of > 0 units) in remaining domain: patient's global assessment of disease activity, pain (as total back pain), and physical function (Bath Ankylosing Spondylitis Function Index [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best response to 100=worst response); and inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disease Activity Index [BASDAI]).

Secondary Outcome Measures:

Number of Participants Achieving ASAS20 Response (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ASAS20 response is improvement of >/=20% and absolute improvement of >/=10 units (scale of 0-100) in >/= 3 of 4 domains, plus no deterioration (worsening of >/=20% and >/=10 units) in remaining domain: patient's global assessment of disease activity, pain (as total back pain), and physical function (Bath Ankylosing Spondylitis Function Index [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best response to 100=worst response); and inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disease Activity Index [BASDAI]).
Number of Participants Achieving a BASDAI50 Response (BASDAI: Bath Ankylosing Spondylitis Disease Activity Index) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (scale 0 to 10 cm) pertaining to symptoms experienced for the past week. For 5 questions (including #5 [level of morning stiffness]), the response is 0 (none) to 10 (very severe); for #6 (duration of morning stiffness), the response is 0 (0 hours) to 10 (>/= 2 hours). The overall BASDAI score has a maximum value of 10 cm. Lower scores indicate less disease activity. BASDAI50 is 50% improvement from Baseline in BASDAI score.
Number of Participants Achieving ASAS Partial Remission (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ASAS partial remission is an absolute score of <20 units on a 0 to 100 scale for each of 4 domains: patient's global assessment of disease activity, pain (as total back pain), and physical function (Bath AS Functional Index score [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best response to 100=worst response); and inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disability Activity Index [BASDAI]).
Number of Participants Achieving ASAS5/6 Response (ASAS: Assessment of Spondyloarthritis International Society) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
ASAS5/6 response is a 20% improvement in 5 of 6 domains: patient's global assessment of disease activity, pain (as total back pain), physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]) (each domain with Visual Analog Scale [mm] scores of 0=best to 100=worst); inflammation (morning stiffness level/duration [items 5 and 6] mean score [cm: 0=best to 10=worst] on Bath AS Disease Activity Index [BASDAI]); spinal mobility (lateral lumbar flexion score (cm: range 0 to 10) from Bath AS Metrology Index [BASMI]); and C-reactive protein level (lower indicates less inflammation).

Enrollment:	192
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2013
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Adalimumab	Biological: Adalimumab 40 mg Every Other week up to Week 12 Other Name: ABT-D2E7, adalimumab, Humira
Placebo Comparator: Placebo	Biological: Placebo Placebo Every Other Week up to Week 12 Other Name: placebo
Experimental: Open-label Adalimumab	Biological: Open-label Adalimumab 40 mg Every Other Week, Week 12 through Week 156 Other Name: ABT-D2E7, adalimumab, Humira

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 1 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 participants enter the open-label phase of the study in which they receive adalimumab for up to an additional 144 weeks.

Efficacy endpoints include the Assessment of Spondyloarthritis International Society (ASAS) Working Group 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 hours to 2 or more hours. The BASDAI score has a maximum value of 10 cm.

The double-blind phase of the study is complete, and results are reported for endpoints at Week 12.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Adult subjects with inadequate response to >/= 1 non-steroidal anti-inflammatories (NSAIDs)
Chronic back pain with onset < 45 years of age
MRI indicating active sacroiliitis or positive 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-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
Female subjects 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939003

Show 38 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Aileen L Pangan, MD

Abbott

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT00939003 History of Changes
Other Study ID Numbers:	M10-791, 2009-010643-14
Study First Received:	July 10, 2009
Results First Received:	February 2, 2012
Last Updated:	March 27, 2012
Health Authority:	Australia: Human Research Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada Czech Republic: State Institute for Drug Control France: Afssaps - French Health Products Safety Agency Germany: Paul-Ehrlich-Institut Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Additional relevant MeSH terms:

Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis

Joint Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2012