Details - Clinical Research

Clinical Research Details

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Descriptive Information

Title

A non-interventional multicenter study of MabThera (rituximab) in combination with methotrexate in patients with active rheumatoid arthritis

Investigator Name

Imad Uthman

iuthman@aub.edu.lb

Protocol Id

ML25270

Status

Completed

Study Type

Observational A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

Phase

Phase 2

Looking for Med Students Volunteers

Sponsors

Roche

Coordinators

Nour Hamadeh

ngh12@aub.edu.lb

Stephanie Hakimian

sh123@aub.edu.lb

Conditions and Keywords

Conditions

Rheumatoid arthritis

Keywords

Rheumatoid arthritis, Rituximab (mabthera), Methotrexate

Study Design

Primary Purpose

Treatment

Classification

Safety and/or Efficacy Study

Time Perspective

Prospective

Masking

Open Label

Intervention Model

Single Group

Allocation

N/A: Not Applicable

Observational Study Model

Case-Only

Eligibility and IRB

Gender

Both

Age Limits

Min: 21

Max:

IRB Approval

Yes

Healthy Volunteer

Study Description

Population Description

Primary care clinic

Sampling Method

Non-probability sample

Inclusion Criteria

Adult (age≥21), patients receiving Mabthera in accordance with the prescribing information, having signed a data release form within 6 weeks (42 days) of initiating Mabthera

Exclusion Criteria

Contra-indication to receive MabThera according to the local labeling Previous treatment with MabThera, Treatment with any investigation drug within 30 days prior to enrollment

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