Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis

Sponsor
Charite University, Berlin, Germany
Study ID
NCT00432653
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To evaluate the efficacy and safety of rituximab when added to NSAIDs and/ or methotrexate both for TNFalpha inhibitor naïve or TNFalpha inhibitor failure patients with moderate to severe ankylosing spondylitis

Key Dates

Start date
Mar 31, 2007
Status verified
Feb 2007
Completion
Nov 30, 2009

Study Design

Enrollment
20 participants
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Evaluation in week 24 and until study end: ASAS 20 in AS patients naïve to TNFalpha inhibitors as well as in AS patients with previous therapy with TNFalpha inhibitors.

Central Contacts

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