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Rituximab in Moderate to Severe Ankylosing Spondylitis: An Open Label Clinical Trial

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What is being tested

Data Collection

Who is being recruted

Axial Spondyloarthritis+8

+ Ankylosis

+ Arthritis

From 18 to 65 Years
+42 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2 & 3
Interventional
Study Start: March 2007
See protocol details

Summary

Principal SponsorCharite University, Berlin, Germany
Study ContactIn-Ho Song, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2007

Actual date on which the first participant was enrolled.

This study focuses on individuals with moderate to severe ankylosing spondylitis, a condition that hasn't responded well to conventional treatments like NSAIDs, DMARDs, and TNF alpha inhibitors. The research is based on the belief that autoimmunity plays a significant role in the development of ankylosing spondylitis. Although there's no direct evidence, it's suggested that the cartilage is the likely target of an autoimmune response in this condition. The study aims to understand if a specific immune response, possibly T cell mediated, against cartilage is relevant in the development of ankylosing spondylitis. The importance of this study lies in its potential to improve the understanding and treatment of this condition. The study involves the use of a drug called Rituximab (MabThera ®) in combination with NSAIDs and/or methotrexate. The main goal is to evaluate the efficacy and safety of this combination for patients who are new to TNFalpha inhibitors, as well as for those who have previously used TNFalpha inhibitors without success. This is an open-label clinical trial that will last for 48 weeks. The study's results will be measured at week 24 and until the end of the study, using a metric called ASAS 20. This metric helps to assess the improvement in symptoms of ankylosing spondylitis.

Official TitleOpen Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis
NCT00432653
Principal SponsorCharite University, Berlin, Germany
Study ContactIn-Ho Song, MDMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Axial SpondyloarthritisAnkylosisArthritisBone DiseasesJoint DiseasesMusculoskeletal DiseasesSpinal DiseasesSpondylitisSpondylitis, AnkylosingSpondylarthritisSpondylarthropathies

Criteria

8 inclusion criteria required to participate
Patients 18 - 65 years of age who have moderate to severe ankylosing spondylitis.
Active disease is defined as a BASDAI score of ³ 4 plus a back pain score (BASDAI question 2) of ³ 4 despite concurrent NSAID therapy, or intolerance to NSAIDs
If on prednisone, £10 mg per day must be stable for 4 weeks prior to baseline.
If on methotrexate, £ 25 mg per week must be stable for 4 weeks prior to baseline
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34 exclusion criteria prevent from participating
Patients with other chronic inflammatory articular disease or systemic autoimmune disease, e.g. Systemic lupus erythematosus,Sjögren's syndrome, active rheumatoid vasculitis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome
Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
Primary or secondary immunodeficiency
History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Charite, Campus Benjamin-Franklin, Med. Clinic I, Rheumatology

Berlin, GermanyOpen Charite, Campus Benjamin-Franklin, Med. Clinic I, Rheumatology in Google Maps
Suspended

Rheumazentrum Ruhrgebiet, St. Josefs Krankenhaus

Herne, Germany
Suspended2 Study Centers