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A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia

1 november 2016 uppdaterad av: Hoffmann-La Roche

A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice

This is a cross-sectional, observational study examining the factors leading to the therapeutic decision to use MabThera (rituximab) in participants with RA. Routine rheumatology clinical practice data of participants who are being or have been treated with rituximab for RA will be collected and analysed in this chart review.

Studieöversikt

Status

Avslutad

Betingelser

Reumatoid artrit

Studietyp

Observationell

Inskrivning (Faktisk)

167

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Australien
- Victoria
  - Geelong, Victoria, Australien, 3220

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Rheumatoid arthritis (RA) participants who have been treated with rituximab

Beskrivning

Inclusion Criteria:

Greater than or equal to (>=) 18 years of age at the time of data collection
RA diagnosed by a rheumatologist
Treatment with rituximab for RA

Exclusion Criteria:

Participants whose primary diagnosis and indication for rituximab treatment is a condition other than RA
Participants who have been treated with an experimental agent for RA which is not currently approved for the treatment of RA in Australia

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Rheumatoid arthritis (RA) participants Participants who had been treated with rituximab for RA are reviewed retrospectively using chart review from Baseline until and their most recent visit to the rheumatologist prior to the conduct of the chart review.

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
Factors leading to Therapeutic decision to use rituximab Tidsram: Up to end of study (approximately 1 month)	Up to end of study (approximately 1 month)

Sekundära resultatmått

Resultatmått	Tidsram
Change in Erythrocyte sedimentation rate Tidsram: Baseline and most recent visits (approximately 1 month)	Baseline and most recent visits (approximately 1 month)
Change in Immunoglobulin levels Tidsram: Baseline and most recent visits (approximately 1 month)	Baseline and most recent visits (approximately 1 month)
Percentage of participants with positive or negative results for rheumatoid factor Tidsram: Up to end of study (approximately 1 month)	Up to end of study (approximately 1 month)
Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody Tidsram: Up to end of study (approximately 1 month)	Up to end of study (approximately 1 month)
Percentage of participants with positive or negative results for anti-nuclear antibodies Tidsram: Up to end of study (approximately 1 month)	Up to end of study (approximately 1 month)
Disease activity score (DAS28) Tidsram: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)	At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Tender joint count (TJC) Tidsram: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)	At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Swollen joint count (SJC) Tidsram: At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)	At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
Duration of treatment with rituximab Tidsram: From first dose to most recent rituximab infusion (approximately 1 month)	From first dose to most recent rituximab infusion (approximately 1 month)
Change in C-reactive protein Tidsram: Baseline and most recent visits (approximately 1 month)	Baseline and most recent visits (approximately 1 month)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Samarbetspartners

Roche Products Pty Ltd (Australia)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2012

Primärt slutförande (Faktisk)

1 februari 2012

Avslutad studie (Faktisk)