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A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor

30 juin 2016 mis à jour par: Hoffmann-La Roche

An Open-label Study to Evaluate the Safety of MabThera, and Its Effect on Treatment Response, in Patients With Rheumatoid Arthritis Following Inadequate Response to a Single Anti-TNF Agent

This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

302

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

  • Allemagne
      • Bad Abbach, Allemagne, 93077
      • Bad Aibling, Allemagne, 83043
      • Bad Bramstedt, Allemagne, 24576
      • Bamberg, Allemagne, 96047
      • Berlin, Allemagne, 10117
      • Berlin, Allemagne, 12200
      • Berlin, Allemagne, 13125
      • Berlin, Allemagne, 13589
      • Berlin, Allemagne, 13055
      • Berlin, Allemagne, 14163
      • Bonn, Allemagne, 53111
      • Bremen, Allemagne, 28199
      • Cuxhaven, Allemagne, 27476
      • Damp, Allemagne, 24351
      • Donaueschingen, Allemagne, 78166
      • Dresden, Allemagne, 01109
      • Düsseldorf, Allemagne, 40225
      • Düsseldorf, Allemagne, 40211
      • Erfurt, Allemagne, 99096
      • Erlangen, Allemagne, 91054
      • Erlangen, Allemagne, 91056
      • Essen, Allemagne, 45326
      • Essen, Allemagne, 45239
      • Frankfurt Am Main, Allemagne, 60590
      • Freiburg, Allemagne, 79106
      • Fulda, Allemagne, 36039
      • GIEßEN, Allemagne, 35392
      • Gommern, Allemagne, 39245
      • Göttingen, Allemagne, 37075
      • Hagen, Allemagne, 58135
      • Halle, Allemagne, 06120
      • Hamburg, Allemagne, 22081
      • Hannover, Allemagne, 30625
      • Hannover, Allemagne, 30159
      • Heidelberg, Allemagne, 69120
      • Herne, Allemagne, 44652
      • Hofheim, Allemagne, 65719
      • Homburg/saar, Allemagne, 66424
      • Jena, Allemagne, 07743
      • Karlsruhe, Allemagne, 76135
      • Köln, Allemagne, 50924
      • Ludwigshafen, Allemagne, 67063
      • Mainz, Allemagne, 55131
      • Mainz, Allemagne, 55122
      • Mittelherwigsdorf, Allemagne, 02763
      • Muenchen, Allemagne, 80336
      • Mönchengladbach, Allemagne, 41061
      • München, Allemagne, 81541
      • München, Allemagne, 80335
      • Münster, Allemagne, 48149
      • Naunhof, Allemagne, 04683
      • Oldenburg, Allemagne, 26121
      • Osnabrück, Allemagne, 49074
      • Pirna, Allemagne, 01796
      • Ratingen, Allemagne, 40882
      • Rostock, Allemagne, 18059
      • Schwerte, Allemagne, 58239
      • Sendenhorst, Allemagne, 48324
      • Stuttgart, Allemagne, 70178
      • Treuenbrietzen, Allemagne, 14929
      • Trier, Allemagne, 54292
      • Tübingen, Allemagne, 72076
      • ULM, Allemagne, 89081
      • Wiesbaden, Allemagne, 65191
      • Wiesbaden, Allemagne, 65189
      • Wuerzburg, Allemagne, 97080
      • Wuppertal, Allemagne, 42105
      • Würselen, Allemagne, 52146
      • Zeven, Allemagne, 27404

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 à 75 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • rheumatoid arthritis for >=6 months;
  • previous inadequate response to a single anti-TNF alpha inhibitor;
  • methotrexate at a stable dose range 7.5-25 mg/week.

Exclusion Criteria:

  • other chronic inflammatory articular disease or systemic autoimmune disease;
  • previous treatment with MabThera or intolerance to MabThera;
  • corticosteroids>=10 mg/day prednisolone within last 2 weeks, or corticosteroids at unstable doses within last 2 weeks;

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: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: MabThera (Rituximab)
Médicament: rituximab [MabThera]
1 g was given by intravenous infusion on Days 1 and 15

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)
Délai: Week 24
The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-ated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Week 24

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
DAS28 Score
Délai: Screening and Weeks 8, 16, and 24
The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Screening and Weeks 8, 16, and 24
Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate
Délai: Weeks 8, 16, and 24
The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of >1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1.
Weeks 8, 16, and 24
Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24
Délai: Week 24
Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
Week 24
Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24
Délai: Week 24
Percentage of participants with remission defined as DAS28 <2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Week 24
Percentage of Participants Achieving a Response By EULAR Category
Délai: Weeks 8, 16, and 24
Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. 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 and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score of >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.
Weeks 8, 16, and 24
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Délai: Screening and Weeks 8, 16, and 24
The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).
Screening and Weeks 8, 16, and 24
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
Délai: Screening and Weeks 8, 16, and 24
The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.
Screening and Weeks 8, 16, and 24
Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)
Délai: Screening and Weeks 8, 16, and 24
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Screening and Weeks 8, 16, and 24
SF-36 Domain Scores
Délai: Screening and Weeks 8, 16, and 24
The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.
Screening and Weeks 8, 16, and 24
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)
Délai: Weeks 8, 16, and 24
ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit.
Weeks 8, 16, and 24
Swollen Joint Count (SJC)
Délai: Screening and Weeks 8, 16, and 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Screening and Weeks 8, 16, and 24
Tender Joint Count (TJC)
Délai: Screening and Weeks 8, 16, and 24
The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.
Screening and Weeks 8, 16, and 24
Physician's Global Assessment of Disease Activity
Délai: Screening and Weeks 8, 16, and 24
Physicians assessed the disease (RA) activity 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) as "maximum disease activity" (maximum arthritis disease activity).
Screening and Weeks 8, 16, and 24
Patient's Assessment of Disease Activity
Délai: Screening and Weeks 8, 16, and 24
Participants were to assess the disease (RA) activity 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) as "maximum disease activity" (maximum arthritis disease activity).
Screening and Weeks 8, 16, and 24
Patient's Assessment of Pain
Délai: Screening and Weeks 8, 16, and 24
Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand (100 mm) as "unbearable pain".
Screening and Weeks 8, 16, and 24
C-Reactive Protein (CRP)
Délai: Screening, Days 1 and 15, and Weeks 8, 16, and 24
Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.
Screening, Days 1 and 15, and Weeks 8, 16, and 24
Erythrocyte Sedimentation Rate (ESR)
Délai: Screening, Days 1 and 15, and Weeks 8, 16, and 24
Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.
Screening, Days 1 and 15, and Weeks 8, 16, and 24
Rheumatoid Factor (RF)
Délai: Screening and Weeks 8, 16, and 24
Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.
Screening and Weeks 8, 16, and 24

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

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 novembre 2006

Achèvement primaire (Réel)

1 novembre 2010

Achèvement de l'étude (Réel)

1 novembre 2010

Dates d'inscription aux études

Première soumission

4 mars 2014

Première soumission répondant aux critères de contrôle qualité

4 mars 2014

Première publication (Estimation)

5 mars 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

29 juillet 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 juin 2016

Dernière vérification

1 juin 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ML19070

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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