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A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

6. Juli 2017 aktualisiert von: Hoffmann-La Roche

Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF

This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

28

Phase

  • Phase 3

Kontakte und Standorte

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

Studienorte

  • Saudi-Arabien
      • Dammam, Saudi-Arabien, 31444
        • King Fahad Specialist Hospital; Oncology
      • Jeddah, Saudi-Arabien, 21589
        • King AbdulAziz University Hospital
      • Makkah, Saudi-Arabien
        • Heraa General Hospital; Rheumatology
      • Riyadh, Saudi-Arabien, 11525
        • King Fahad Medical City; Gastroentrology

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Active moderate to severe rheumatoid arthritis of >/= 6 months duration
  • >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment
  • Inadequate clinical response to non-biologic DMARD or anti-TNF therapy
  • Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug

Exclusion Criteria:

  • Pregnant or lactating women
  • Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment
  • Rheumatic autoimmune disease other than RA
  • Functional class IV (ACR classification)
  • Prior history of or current joint disease other than RA
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Previous treatment with RoActemra/Actemra
  • Known active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency
  • Active tuberculosis requiring treatment within the previous 3 years
  • Positive for HIV

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Einarmig
Arzneimittel: tocilizumab [RoActemra/Actemra]
8 mg/kg (max. 800 mg) iv every 4 weeks, 6 infusions

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Zeitfenster: Up to 1 year
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Up to 1 year
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Zeitfenster: Up to 1 year
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Up to 1 year
Time to Das28 Remission
Zeitfenster: Up to 1 year
Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Up to 1 year
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Zeitfenster: Up to 1 year
DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Up to 1 year
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Zeitfenster: Up to 1 year
DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Up to 1 year
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Zeitfenster: Up to 1 year
Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.
Up to 1 year
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Zeitfenster: Up to 1 year
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Up to 1 year
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Zeitfenster: Up to 1 year
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Up to 1 year

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Any Adverse Event and Serious Adverse Event
Zeitfenster: Up to 1 year
An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.
Up to 1 year
Number of Participants With AE or SAE Related Discontinuation of Tocilizumab
Zeitfenster: Up to 1 year
It included participants who discontinued from the study due to occurrence of AE or SAE.
Up to 1 year
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
Zeitfenster: Up to 1 year
ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]).
Up to 1 year
Number of Participants With C-Reactive Protein Abnormality
Zeitfenster: Up to 1 year
CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).
Up to 1 year
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Zeitfenster: Up to 1 year
ESR is an acute phase reactant and is a measure of inflammation. It is measured in millimeter per hour (mm/hr).
Up to 1 year

Mitarbeiter und Ermittler

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

Sponsor

Hoffmann-La Roche

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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 (Tatsächlich)

30. November 2011

Primärer Abschluss (Tatsächlich)

12. Mai 2013

Studienabschluss (Tatsächlich)

12. Mai 2013

Studienanmeldedaten

Zuerst eingereicht

7. März 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. März 2011

Zuerst gepostet (Schätzen)

31. März 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. August 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2017

Zuletzt verifiziert

1. Juli 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ML22726

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