An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)
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ClinicalTrials.gov Identifier: NCT01075477 |
Recruitment Status :
Completed
First Posted : February 25, 2010
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment |
---|---|
Rheumatoid Arthritis | Drug: rituximab [Mabthera/Rituxan] |
Study Type : | Observational |
Actual Enrollment : | 151 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Naturalistic Prospective Non-interventional Study on Rheumatoid Arthritis (RA) Patients Treated With Rituximab According to Local Treatment Guidelines |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Group/Cohort | Intervention/treatment |
---|---|
Cohort |
Drug: rituximab [Mabthera/Rituxan]
As prescribed by physician |
- Efficacy: DAS28 [ Time Frame: 29 months ]
- Efficacy: TJC, SJC, ESR, HAQ, CRP, patient's assessment (VAS) [ Time Frame: 29 months ]
- Safety: serious and non-serious adverse events [ Time Frame: 29 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- adult patients, >/= 18 years of age
- rheumatoid arthritis
- treatment with rituximab
Exclusion Criteria:
- unable/unwilling to give informed consent to data collection

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075477
Finland | |
Helsinki, Finland, 00290 | |
Hämeenlinna, Finland, 13530 | |
Joensuu, Finland, 80210 | |
Jyvaeskylae, Finland, 40620 | |
Paimio, Finland, 21540 | |
Riihimäki, Finland, 11101 | |
Seinäjoki, Finland, 60220 | |
Tampere, Finland, 33520 |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01075477 |
Other Study ID Numbers: |
ML22609 |
First Posted: | February 25, 2010 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |