Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

7. července 2016 aktualizováno: Hoffmann-La Roche

Non-interventional, Prospective, Multicenter Study to Assess Efficacy and Safety of MabtheRA (Rituximab) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to One Anti-TNF Agent - FAST 2 SWITCH Program

This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Aktuální)

505

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

Participants with active rheumatoid arthritis and an inadequate response or intolerant to one prior anti-TFN therapy initiated on treatment with MabThera/Rituxan

Popis

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Participants with rheumatoid arthritis, eligible for treatment with MabThera/Rituxan in accordance with summary of product characteristics (SPC)
  • Inadequate response to a single TNF inhibitor defined as change in disease activity score-28 erythrocyte sedimentation rate (DAS28-ESR) <1.2 or DAS28-ESR >3.5 at 5 months after first course of anti-TNF therapy
  • Participants with a clinical and biological evaluation performed within 12 weeks prior to enrollment may be included

Exclusion Criteria:

  • More than one previous anti-TNF therapies
  • Any other biological therapy apart from the one anti-TNF therapy
  • Hypersensitivity to rituximab or any of the excipients or to murine proteins
  • Active severe infections
  • Participants in a severely immunocompromised state
  • Severe heart failure [New York Heart Association (NYHA) Class IV] or severe, uncontrolled cardiac disease
  • Women of childbearing potential not willing to use contraception
  • Pregnant or breastfeeding women
  • Participation in another trial

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Kohorta
  • Časové perspektivy: Budoucí

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Rituximab
Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Lék: Rituximab
Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Ostatní jména:
  • Mabthera

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria
Časové okno: Week 20
The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
Week 20
Change From Baseline in DAS28-ESR at Week 20
Časové okno: Baseline and Week 20
DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity [measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity]. DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
Baseline and Week 20
Mean DAS28-ESR Score at Visit 4 (Week 20)
Časové okno: Week 20
DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
Week 20
Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment
Časové okno: Week 20
DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
Week 20
Percentage of Participants With EULAR Response
Časové okno: Week 20
The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
Week 20
Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously
Časové okno: Week 20
The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
Week 20
Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course
Časové okno: Week 20
DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.
Week 20
Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab
Časové okno: Week 20
The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline (CFB) indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.
Week 20
Number of Participants With Adverse Events (AE)
Časové okno: Up to 39 months
An AE was defined as any unfavorable 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.
Up to 39 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Health Assessment Questionnaire (HAQ) Score at Week 20
Časové okno: Baseline and Week 20
HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA). 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 3=unable to do. Calculate HAQ the patient must have a domain score for at least 6 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.
Baseline and Week 20

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2011

Primární dokončení (Aktuální)

1. ledna 2015

Dokončení studie (Aktuální)

1. ledna 2015

Termíny zápisu do studia

První předloženo

13. července 2012

První předloženo, které splnilo kritéria kontroly kvality

13. července 2012

První zveřejněno (Odhad)

17. července 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

17. srpna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. července 2016

Naposledy ověřeno

1. července 2016

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ML27953

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Rituximab

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Turkmenistan

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

3
Předplatit