Clinical trial NCT00576433: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
Official title: An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-80 years of age;
* moderate to severe active rheumatoid arthritis;
* inadequate response to previous or current treatment with 1 anti-TNF agent;
* receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for \>=4 weeks.

Exclusion Criteria:

* previous treatment with MabThera;
* use of an anti-TNF alpha agent within 8 weeks of study start;
* concurrent treatment with any DMARD other than methotrexate;
* active infection, or history of serious recurrent or chronic infection.

Primary outcomes:
measure: AEs, including infusion-related adverse events
timeFrame: For 48 weeks after initial treatment
Secondary outcomes:
measure: Safety of re-treatment (AEs)
timeFrame: For 24 weeks after re-treatment.
measure: Laboratory parameters, vital signs.
timeFrame: Throughout study
measure: ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.
timeFrame: For 48 weeks after initial treatment.
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Khanty-Mansiysk
country: Russian Federation
city: Kursk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Tjumen
country: Russian Federation
city: UFA
country: Russian Federation
city: Vladivostok
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: