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An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

6. Juli 2016 aktualisiert von: Hoffmann-La Roche

A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

90

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Korea, Republik von
      • Busan, Korea, Republik von, 48108
      • Daegu, Korea, Republik von, 41931
      • Daegu, Korea, Republik von, 42472
      • Daejeon, Korea, Republik von, 302-799
      • Gwangju, Korea, Republik von, 61469
      • Gyeonggi-do, Korea, Republik von, 10380
      • Jeju Special Self-Governing Province, Korea, Republik von, 63241
      • Jeollabuk-do, Korea, Republik von, 561-712
      • Seoul, Korea, Republik von, 150-713
      • Seoul, Korea, Republik von, 130-702
      • Seoul, Korea, Republik von, 05030
      • Seoul, Korea, Republik von, 06273
      • Seoul, Korea, Republik von, 134-722
      • Suwon, Korea, Republik von, 442-723
      • Ulsan, Korea, Republik von, 44033

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.

Beschreibung

Inclusion Criteria:

  • Adult participants, >/=20 years of age
  • Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy

Exclusion Criteria:

  • Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
  • Participants who have not signed the informed consent form

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
Arzneimittel: Rituximab
Rituximab as per physician's discretion.
Andere Namen:
  • Mabthera
Other anti-TNF agent
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.
Arzneimittel: Adalimumab
Adalimumab as per physician's discretion.
Arzneimittel: Etanercept
Etanercept as per physician's discretion.
Arzneimittel: Infliximab
Infliximab as per physician's discretion.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
Zeitfenster: Baseline and Month 6
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Month 6
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
Zeitfenster: Baseline and Month 6
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Month 6

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Efficacy: Mean Change From Baseline in DAS28 at Month 12
Zeitfenster: Baseline and Month 12
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Month 12
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Zeitfenster: Baseline, Month 6 and 12
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Zeitfenster: Baseline, Month 6 and 12
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Zeitfenster: Baseline, Month 6 and 12
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Zeitfenster: Baseline, Month 6 and 12
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Zeitfenster: Baseline, Month 6 and 12
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Zeitfenster: Baseline, Month 6 and 12
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Zeitfenster: Baseline, Month 6 and 12
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Zeitfenster: Baseline, Month 6 and 12
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
Zeitfenster: Month 6
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Month 6
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
Zeitfenster: Month 6
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Month 6
Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Zeitfenster: Baseline up to Month 12
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Baseline up to Month 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2011

Primärer Abschluss (Tatsächlich)

1. Dezember 2014

Studienabschluss (Tatsächlich)

1. Dezember 2014

Studienanmeldedaten

Zuerst eingereicht

11. April 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Mai 2012

Zuerst gepostet (Schätzen)

7. Mai 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

22. August 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2016

Zuletzt verifiziert

1. März 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ML27923

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