Trials Sponsors Conditions Drugs Pricing

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (3)

ASAS 20/40/50/70
ASAS 5/6
BASDAI score

Secondary Outcomes (3)

Adverse events
Laboratory data
Vital signs

Interventions

adalimumab (Humira)Drug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Able and willing to give written informed consent and to comply with the requirements of the study protocol
Males and females 18 years of age or older

Sponsors & Collaborators

Abbott
Industrylead

Study Sites (205)

Graz, A-8020, Austria

Graz, A-8036, Austria

Innsbruck, A-6020, Austria

Vienna, A-1090, Austria

Vienna, A-1100, Austria

Aalst, 9300, Belgium

Belsele, B-9111, Belgium

Bruges, 8000, Belgium

Related Publications (4)

Rudwaleit M, Van den Bosch F, Kron M, Kary S, Kupper H. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.
PMID: 20553600DERIVED
Rudwaleit M, Claudepierre P, Kron M, Kary S, Wong R, Kupper H. Effectiveness of adalimumab in treating patients with ankylosing spondylitis associated with enthesitis and peripheral arthritis. Arthritis Res Ther. 2010;12(2):R43. doi: 10.1186/ar2953. Epub 2010 Mar 15.
PMID: 20230622DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized

Study Officials

Beverly Paperiello
Abbott
STUDY DIRECTOR

Enrollment

1,250 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 25, 2007

Study Start

February 2006

Date type not reported

This date has not been verified as actual or estimated.

An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (205)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (205)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations