Status:
UNKNOWN
Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 s...
Detailed Description
Indication: Moderate to severe ankylosing spondylitis who have had an inadequate response to or do not tolerate conventional therapy including NSAIDs, DMARDs and TNF alpha inhibitors. Rationale: We h...
Eligibility Criteria
Inclusion
- 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
- If on sulfasalazine, must be stable 4 weeks prior to basline
- Women of child bearing potential must have a negative pregnancy urine test at study baseline and use an adequate, effective method of contraception (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, vasectomised partner) for a duration of 12 months after stop of rituximab therapy.
- Sexual active men must use an accepted method of contraception for a duration of 12 months after first administration of rituximab.
- Willingness and capability to give written informed consent, written consent for data protection (legal requirement in Germany: datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study
Exclusion
- Exclusion criteria related to general health conditions
- 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
- A history of pulmonary or cardiac insufficiency, or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
- Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease ( e.g. heart failure class III/IV NYHA, cardiac infarct within last 6 month), nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
- Neuropathy that can interfere with quality of life and/or pain assessment.
- Patients with a history of a severe psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
- History of current evidence of abuse of "hard" drugs (e.g. cocaine/ heroine) or alcoholism
- Known hypersensitivity to any component of the product or to murine proteins (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, HCl).
- Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test (urine test)
- Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier) for up to 12.5 months after first infusion of rituximab
- History of alcohol, drug or chemical abuse within 6 month prior to screening
- Lack of peripheral venous access
- Exclusion criteria related to medications
- Obligatory indication for initiation of established therapy, e.g. with TNFalpha-inhibitors
- If on leflunomide, leflunomide must have been terminated at least 8 weeks prior to the first rituximab infusion (or ≥ 28 days after 11 days of standard cholestyramine or activated charcoal washout).
- If on TNFalpha blocking agent (infliximab, etancercept, adalimumab), the TNFa therapy must have been terminated at least 4 weeks prior to the first rituximab infusion if etanercept was used and at least 8 weeks if infliximab or adalimumab were used
- Previous treatment with rituximab or intolerance to rituximab
- Corticosteroids at doses exceeding 10 mg per day of prednisolone or the equivalent within the last 4 weeks prior to the first rituximab infusion
- Intolerance or contraindication to drugs required for the treatment of the side effects of rituximab (e.g. paracetamol, acetaminophen, diphenhydramine, p.o. and i.v. corticosteroids, anti-emetics or H1 blockers
- Previous treatment with any investigational agent
- Previous treatment with i.v. immunoglobulins
- Receipt of a live vaccine within 4 weeks prior to treatment
- Intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit
- Exclusion criteria related to lab findings
- Haemoglobin \< 8.5 g/dl
- Neutrophil counts \< 2.000 / µl
- Platelet count \< 125.000 / µl
- Lower than 1 x 1000/µl lymphopenia for more than three months prior to inclusion.
- Serum creatinine \> 1.4 mg/dl for women or 1.6 mg/dl for men.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 times upper limit of normal
- Positive HIV, hepatitis B or C serology
- Exclusion criteria related to formal aspects
- Patients who participate currently in another clinical trial or patients who participated in another clinical trial during the last 30 days.
- Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
- Patients who are institutionalised due to regulatory or juridical order (according to AMG § 40 (1) Abs. 4)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
End Date :
November 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00432653
Start Date
March 1 2007
End Date
November 1 2009
Last Update
February 8 2007
Active Locations (2)
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1
Charite, Campus Benjamin-Franklin, Med. Clinic I, Rheumatology
Berlin, Germany, 12200
2
Rheumazentrum Ruhrgebiet, St. Josefs Krankenhaus
Herne, Germany, 44652