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. juli 2016 oppdatert av: 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.
Studieoversikt
Studietype
Observasjonsmessig
Registrering (Faktiske)
505
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bucuresti, Romania, 020983
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Participants with active rheumatoid arthritis and an inadequate response or intolerant to one prior anti-TFN therapy initiated on treatment with MabThera/Rituxan
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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.
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Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria
Tidsramme: Week 20
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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.
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Week 20
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Change From Baseline in DAS28-ESR at Week 20
Tidsramme: Baseline and Week 20
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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.
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Baseline and Week 20
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Mean DAS28-ESR Score at Visit 4 (Week 20)
Tidsramme: Week 20
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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.
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Week 20
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Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment
Tidsramme: Week 20
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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.
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Week 20
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Percentage of Participants With EULAR Response
Tidsramme: Week 20
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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.
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Week 20
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Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously
Tidsramme: Week 20
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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.
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Week 20
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Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course
Tidsramme: Week 20
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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.
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Week 20
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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
Tidsramme: Week 20
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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.
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Week 20
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Number of Participants With Adverse Events (AE)
Tidsramme: Up to 39 months
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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.
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Up to 39 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Health Assessment Questionnaire (HAQ) Score at Week 20
Tidsramme: Baseline and Week 20
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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.
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Baseline and Week 20
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2011
Primær fullføring (Faktiske)
1. januar 2015
Studiet fullført (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først innsendt
13. juli 2012
Først innsendt som oppfylte QC-kriteriene
13. juli 2012
Først lagt ut (Anslag)
17. juli 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Autoimmune sykdommer
- Leddsykdommer
- Muskel- og skjelettsykdommer
- Revmatiske sykdommer
- Bindevevssykdommer
- Leddgikt
- Leddgikt, revmatoid
- Fysiologiske effekter av legemidler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Rituximab
Andre studie-ID-numre
- ML27953
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