A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
3 novembre 2014 mis à jour par: Hoffmann-La Roche
Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs).
Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions.
Methotrexate will be continued at a stable dose.
Anticipated time on study treatment is 24 weeks.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
71
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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Banja Luka, Bosnie Herzégovine, 78 000
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Sarajevo, Bosnie Herzégovine, 71000
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Tuzla, Bosnie Herzégovine, 75000
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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
- Active moderate to severe rheumatoid arthritis (RA)
- On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
- Oral corticosteroids must have been at stable dose of </= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
- 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 study entry
- Rheumatic autoimmune disease other than RA
- Functional class IV according to American College of Rheumatology (ACR) classification
- Prior history of or current inflammatory joint disease other then RA
- Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
- Treatment with any biologic drug that is used in the treatment or RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Positive for HIV
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 |
|---|---|
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Expérimental: Bras unique
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stable dose as prescribed
8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Délai: Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24
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AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24.
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Screening Visit, 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 |
|---|---|---|
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Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit
Délai: Baseline, Weeks 8, 16 and 24
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DAS28 was calculated using the 28 joints count, the C-reactive protein levels (CRP) and participant's global assessment (PtGA) of disease activity. The following formula was used to determine DAS28. DAS28 (equals) = 0.56 × (square root of) √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100- millimeter [mm] visual analog scale [ VAS]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. |
Baseline, Weeks 8, 16 and 24
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Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28
Délai: Weeks 8, 16 and 24
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DAS28 was calculated using the 28 joints count, the CRP and PtGA of disease activity. The following formula was used to determine DAS28. DAS28 = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100-mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Participants were considered to have low disease activity when DAS28 was less than or equal to (≤) 3.2 and in clinical remission when DAS28 scores were less than (<) 2.6 |
Weeks 8, 16 and 24
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Swollen and Tender Joint Counts
Délai: Baseline, Weeks 8, 16 and 24
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66 and 68 joints were assessed by the physician for tenderness or swelling respectively.
The joints were counted as tender/not tender (tender=1; not tender=0) and swollen/not swollen (swollen=1; not swollen=0) and scored.
The scores ranged from 0 to 66 for TJC and 0 to 68 for SJC.
A negative change from baseline represents an improvement.
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Baseline, Weeks 8, 16 and 24
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Physician's Global Assessment of Disease Activity
Délai: Baseline, Weeks 8, 16 and 24
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Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100).
The distance in mm from the left edge of the scale was measured.
Higher scores indicated higher disease activity.
A negative change from baseline represents an improvement.
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Baseline, Weeks 8, 16 and 24
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Participant's Global Assessment of Disease Activity
Délai: Baseline, Weeks 8, 16 and 24
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Participant's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100).
The distance in mm from the left edge of the scale was measured.
Higher scores indicated higher disease activity.
A negative change from baseline represents an improvement.
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Baseline, Weeks 8, 16 and 24
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Participant's Global Assessment of Pain
Délai: Baseline, Weeks 8, 16 and 24
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Participant's global assessment of pain was performed using a 100 mm VAS ranging from no pain (0) at the left edge to unbearable pain (100) at the right edge.
The distance in mm from the left edge of the scale was measured.
A negative change from baseline represents an improvement.
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Baseline, Weeks 8, 16 and 24
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CRP Levels
Délai: Baseline, Weeks 8, 16 and 24
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CRP is a marker of acute phase inflammation and is measured in mg/L.
A negative change from baseline represents an improvement.
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Baseline, Weeks 8, 16 and 24
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Erythrocyte Sedimentation Rate (ESR)
Délai: Baseline, Weeks 8, 16 and 24
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ESR is a marker of inflammation and is measured in millimeters per hour (mm/hour).
A negative change from baseline represents an improvement.
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Baseline, Weeks 8, 16 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 février 2011
Achèvement primaire (Réel)
1 décembre 2012
Achèvement de l'étude (Réel)
1 décembre 2012
Dates d'inscription aux études
Première soumission
15 octobre 2010
Première soumission répondant aux critères de contrôle qualité
4 novembre 2010
Première publication (Estimation)
5 novembre 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 novembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 novembre 2014
Dernière vérification
1 novembre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies auto-immunes
- Maladies articulaires
- Maladies musculo-squelettiques
- Maladies rhumatismales
- Maladies du tissu conjonctif
- Arthrite
- Arthrite, rhumatoïde
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs de la synthèse des acides nucléiques
- Inhibiteurs d'enzymes
- Agents antirhumatismaux
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents dermatologiques
- Agents de contrôle de la reproduction
- Agents abortifs, non stéroïdiens
- Agents abortifs
- Antagonistes de l'acide folique
- Méthotrexate
Autres numéros d'identification d'étude
- ML25303
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