- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01610791
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)
8 juillet 2014 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
121
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Casablanca, Maroc, 20000
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Fés, Maroc, 30000
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Khouribga, Maroc, 14000
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Kénitra, Maroc, 25000
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Marrakech, Maroc, 40000
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Meknés, Maroc, 50000
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Rabat, Maroc, 10000
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Salé, Maroc, 15045
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Bras unique
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8 mg/kg iv every 4 weeks, total of 6 infusions
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants With Adverse Events
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Délai: Weeks 4, 8, 12, 16, 20, and 24
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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'.
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Weeks 4, 8, 12, 16, 20, and 24
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Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
Délai: Baseline through Week 24
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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.
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Baseline through Week 24
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Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
Délai: Baseline through Week 24
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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.
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Baseline through Week 24
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Percentage of Participants With Lipid Elevations by Study Visit
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Disease Activity Score Based on 28-Joint Count (DAS28)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Percentage of Participants by DAS28 Response Category
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Time to Achieve Clinically Meaningful Reduction in DAS28
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Percentage of Participants Achieving Remission (DAS28 <2.6)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
Délai: Weeks 4, 8, 12, 16, 20, and 24
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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)
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Weeks 4, 8, 12, 16, 20, and 24
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Swollen and Tender Joint Counts
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Health Assessment Questionnaire (HAQ)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Patient Global Assessment of Disease Activity (VAS)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Physician's Global Assessment of Disease Activity (VAS)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Patient Assessment of of Pain (VAS)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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C-Reactive Protein (CRP)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Erythrocyte Sedimentation Rate (ESR)
Délai: Baseline, Weeks 4, 8, 12, 16, 20, and 24
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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.
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Baseline, Weeks 4, 8, 12, 16, 20, and 24
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2010
Achèvement primaire (Réel)
1 août 2011
Achèvement de l'étude (Réel)
1 août 2011
Dates d'inscription aux études
Première soumission
31 mai 2012
Première soumission répondant aux critères de contrôle qualité
1 juin 2012
Première publication (Estimation)
4 juin 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
10 juillet 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juillet 2014
Dernière vérification
1 juillet 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ML22638
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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