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A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)

8. července 2014 aktualizováno: Hoffmann-La Roche

A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)

This open label, single arm study will assess the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks for 24 weeks (6 infusions).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

121

Fáze

  • Fáze 3

Kontakty a umístění

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

Studijní místa

  • Maroko
      • Casablanca, Maroko, 20000
      • Fés, Maroko, 30000
      • Khouribga, Maroko, 14000
      • Kénitra, Maroko, 25000
      • Marrakech, Maroko, 40000
      • Meknés, Maroko, 50000
      • Rabat, Maroko, 10000
      • Salé, Maroko, 15045

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

Popis

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe active rheumatoid arthritis (DAS28 > 3.2 at screening)
  • Inadequate response to DMARDs
  • Body weight < 150 kg

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of enrollment
  • Rheumatic autoimmune disease other than RA
  • American College of Rheumatology (ACR) functional class IV
  • Prior history of or current inflammatory joint disease other than RA
  • Previous treatment with any biologic drug that is used in the treatment of RA
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Pregnant or lactating women
  • Active current or history of recurrent infection, active TB within the previous 3 years, HIV infection

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

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Jednoručka
Lék: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, total of 6 infusions

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Adverse Events
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.
Baseline, Weeks 4, 8, 12, 16, 20, and 24

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Časové okno: Weeks 4, 8, 12, 16, 20, and 24
Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.
Weeks 4, 8, 12, 16, 20, and 24
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
Časové okno: Baseline through Week 24
The difference between baseline and highest values until Week 24 of ALT and AST. The values are measures as international units per liter (UI/L). The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.
Baseline through Week 24
Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
Časové okno: Baseline through Week 24
Levels of LDL and TC were measured in milligrams/deciliter (mg/dL). Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.
Baseline through Week 24
Percentage of Participants With Lipid Elevations by Study Visit
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL. Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable <200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low <40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal <150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Disease Activity Score Based on 28-Joint Count (DAS28)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants by DAS28 Response Category
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 =low disease activity, DAS28 >3.2 to ≤5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Time to Achieve Clinically Meaningful Reduction in DAS28
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units. Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants Achieving Remission (DAS28 <2.6)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants with a DAS28 score <2.6 were considered to have achieved remission.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
Časové okno: Weeks 4, 8, 12, 16, 20, and 24
The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)
Weeks 4, 8, 12, 16, 20, and 24
Swollen and Tender Joint Counts
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The following 28 joints were assessed by the physician for tenderness : metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The change in SJC and TJC was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Health Assessment Questionnaire (HAQ)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
HAQ was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple-choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The change in HAQ was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Patient Global Assessment of Disease Activity (VAS)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity" (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Physician's Global Assessment of Disease Activity (VAS)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity". The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician. The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Patient Assessment of of Pain (VAS)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no pain" and the right-hand extreme of the line (100 mm) was described as "unbearable pain". The change in participant's perception of pain was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
C-Reactive Protein (CRP)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
CRP is an acute phase inflammatory marker. Levels of CRP increase with inflammation. The change in CRP was determined as the difference in values from baseline and at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Erythrocyte Sedimentation Rate (ESR)
Časové okno: Baseline, Weeks 4, 8, 12, 16, 20, and 24
ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The change in ESR was determined as the difference in values from baseline at each visit.
Baseline, Weeks 4, 8, 12, 16, 20, and 24

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. března 2010

Primární dokončení (Aktuální)

1. srpna 2011

Dokončení studie (Aktuální)

1. srpna 2011

Termíny zápisu do studia

První předloženo

31. května 2012

První předloženo, které splnilo kritéria kontroly kvality

1. června 2012

První zveřejněno (Odhad)

4. června 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

10. července 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

8. července 2014

Naposledy ověřeno

1. července 2014

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

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Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

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produkt vyrobený a vyvážený z USA

Ne

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 .

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