D2E7-Early AS

2014-07-23 21:47:30 | BioPortfolio


Reduction of signs and symptoms in patients with moderate to severely early axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to or do not tolerate NSAID therapy.

Study Objectives:Efficacy –To assess whether patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) will show response when adalimumab is added to the pre-existing or in case of intolerance to NSAID therapy. Response will be measured at week 12 by change of efficacy parameters compared to baseline.Safety – To demonstrate the safety of adalimumab in study patients with moderate to severely active early axial spondyloarthritis (without radiological sacroiliitis) in patients who have had an inadequate response to or do not tolerate NSAID therapy.


The study is a two center 12-week double-blind, placebo-controlled trial of adalimumab in patients with moderate to severely active axial spondyloarthritis (without radiological sacroiliitis) who have had an inadequate response to who are or intolerant to NSAID therapy. Patients may have been treated in the past with concomitant DMARDs. For these patients a washout period of at least 4 weeks is necessary. If Leflunomide was discontinued, it should be stopped at least 3 months or should be washed out within 4 weeks before study start. Patients who have been treated previously with approved biologics are allowed to enter the study if they failed due to lack of efficacy and/or intolerance. The placebo-controlled treatment period of 12 weeks will be followed by an open-label maintenance therapy up to Week 52. Following screening and baseline evaluations, patients will be assessed at Weeks 2, 4, 8, and 12. During the maintenance therapy visits will be performed at Weeks 16, 20 and every eight weeks thereafter.Efficacy and safety measurements will be recorded throughout the entire 52 weeks study.Non-responders (fail to reach ASAS 40) at and after week 12 of open label therapy (at week 24), will be eligible for adalimumab dose escalation to 40 mg weekly.The study will be followed by a 24 weeks follow up phase. During this period the patients will be assessed every eight weeks.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Ankylosing Spondylitis


Adalimumab 40 mg sc every other week


Charité Campus Benjamin Franklin, Rheumatology


Active, not recruiting


Charite University, Berlin, Germany

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:47:30-0400

Clinical Trials [416 Associated Clinical Trials listed on BioPortfolio]

Effect of the Combination of Methotrexate and Adalimumab on Reduction of Immunization in Ankylosing Spondylitis (COMARIS)

The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an ina...

Safety and Efficacy of Adalimumab in Patients With Active Ankylosing Spondylitis

The purpose of the study is to assess the safety and clinical efficacy of adalimumab in subjects with active ankylosing spondylitis

A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis

The current study will assess the real - life effectiveness of adalimumab in the management of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of extra-articular...

PubMed Articles [2059 Associated PubMed Articles listed on BioPortfolio]

Evaluation of the efficacy and safety of β-d-mannuronic acid in patients with ankylosing spondylitis: A 12-week randomized, placebo-controlled, phase I/II clinical trial.

To evaluate the efficacy, safety and tolerability of β-d-mannuronic acid (M2000) in the treatment of ankylosing spondylitis (AS).

Low-dose CT detects more progression of bone formation in comparison to conventional radiography in patients with ankylosing spondylitis: results from the SIAS cohort.

To compare the CT Syndesmophyte Score (CTSS) for low-dose CT (ldCT) with the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) for conventional radiographs (CR) in patients with ankylosing sp...

Cause analysis of spinal surgery in ankylosing spondylitis.

To investigate the common cause of spinal surgery in ankylosing spondylitis (AS) and to develop reasonable and effective treatment programs for rhematologists.

Complications of total hip arthroplasty in patients with ankylosing spondylitis.

To compare the risks of complications of primary total hip arthroplasty (THA) between patients with ankylosing spondylitis (AS) and those without AS.

Inflammation Intensity-dependent Expression of Osteoinductive Wnt Proteins is Critical for Ectopic New Bone Formation in Ankylosing Spondylitis.

To investigate the molecular mechanism underlying the inflammation- related ectopic new bone formation in ankylosing spondylitis (AS).

Medical and Biotech [MESH] Definitions

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.

A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).

A recombinant version of soluble human TNF receptor that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS.

Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.

More From BioPortfolio on "D2E7-Early AS"

Quick Search


Relevant Topic

Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Searches Linking to this Trial