- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01587989
A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate
22. juni 2015 oppdatert av: Hoffmann-La Roche
A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate.
Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks.
Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks.
Anticipated time on study treatment is 6 months.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
77
Fase
- Fase 3
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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Graz, Østerrike, 8036
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Graz-Eggenberg, Østerrike, 8020
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Hollabrunn, Østerrike, 2020
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Innsbruck, Østerrike, 6020
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Linz, Østerrike, 4020
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Salzburg, Østerrike, 5020
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Stockerau, Østerrike, 2000
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Wels, Østerrike, 4600
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Wien, Østerrike, 1100
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Wien, Østerrike, 1130
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Wien, Østerrike, 1160
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Wien, Østerrike, 1090
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Wien, Østerrike, 1140
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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
Beskrivelse
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Rheumatoid arthritis of >/= 1 year duration
- Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)
- On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
- Body weight </= 150 kg
- Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Functional class IV American College of Rheumatology (ACR) Classification
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Treatment with a biologic agent at any time prior to baseline
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Previous treatment with tocilizumab
- Pregnant or lactating women
- Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
- History of or currently active primary or secondary immunodeficiency
- Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for HIV infection
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: A Methotrexate
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15-25 mg orally weekly, Weeks 1-12
15-25 mg orally weekly, Weeks 13-24
8 mg/kg iv every 4 weeks, 24 weeks
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Eksperimentell: B Methotrexate Placebo
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15-25 mg orally weekly, Weeks 1-12
15-25 mg orally weekly, Weeks 13-24
8 mg/kg iv every 4 weeks, 24 weeks
methotrexate placebo orally weekly, Weeks 13-24
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change From Week 12 (Randomization) to Week 24 in DAS28
Tidsramme: Weeks 12 and 24
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The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA).
The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity).
DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)].
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants With DAS28 Remission at Week 24
Tidsramme: Week 24
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The DAS28 is a combined index for measuring disease activity in RA.
The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity).
DAS28 was calculated according to the following formula: DAS28 = 0.56 * √ of TJC + 0.28 * √ of SJC + 0.70 * ln ESR mm/hr + 0.014 * GH in mm VAS.
DAS28 < 2.6 = remission.
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Week 24
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vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
Tidsramme: Week 24
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The CDAI is a combined index for measuring disease activity in RA.
CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS.
CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA.
CDAI < 2.8 = remission.
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Week 24
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Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24
Tidsramme: Week 24
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The SDAI is a combined index for measuring disease activity in RA.
SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal < 1 mg/dL.
CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP.
SDAI < 3.3 = remission.
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Week 24
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Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24
Tidsramme: Week 24
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The RADAI-5 is a combined index for measuring disease activity in RA.
RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months?
(0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling?
(0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today?
(0 = no pain to 10 = unbearable pain); how would you describe your general health today?
(0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning?
If yes, how long did this stiffness last?
(0 = no stiffness to 10 = stiffness the whole day).
RADAI was calculated according to the following formula: [question (Q) 1 + Q2 + Q3 + Q4 + Q5]/5.
RADAI-5 from 0-1.4 = remission.
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Week 24
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Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Tidsramme: Weeks 12 and 24
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HAQ-DI scores were obtained by scoring participants' responses to a 20-item questionnaire.
HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do).
The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst).
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score
Tidsramme: Weeks 12 and 24
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SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire.
SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst).
The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning).
These 8 aspects were summarized as physical and mental component scores.
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores
Tidsramme: Weeks 12 and 24
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VAS scores were obtained by scoring participants' disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale.
The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity).
A negative change from randomization indicated improvement.
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Weeks 12 and 24
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Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Tidsramme: Week 24
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TSQM scores were obtained by scoring participants' responses to a 14-item questionnaire.
TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.
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Week 24
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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. februar 2012
Primær fullføring (Faktiske)
1. februar 2014
Studiet fullført (Faktiske)
1. februar 2014
Datoer for studieregistrering
Først innsendt
12. mars 2012
Først innsendt som oppfylte QC-kriteriene
26. april 2012
Først lagt ut (Anslag)
30. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
17. juli 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juni 2015
Sist bekreftet
1. juni 2015
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
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehemmere
- Enzymhemmere
- Antirevmatiske midler
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Dermatologiske midler
- Reproduktive kontrollmidler
- Abortfremkallende midler, ikke-steroide
- Aborterende midler
- Folsyreantagonister
- Metotreksat
Andre studie-ID-numre
- ML27837
- 2011-001863-39 (EudraCT-nummer)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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