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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 juni 2016 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

302

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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;

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MabThera (Rituximab)
Läkemedel: rituximab [MabThera]
1 g was given by intravenous infusion on Days 1 and 15

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
DAS28 Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Hoffmann-La Roche

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2006

Primärt slutförande (Faktisk)

1 november 2010

Avslutad studie (Faktisk)

1 november 2010

Studieregistreringsdatum

Först inskickad

4 mars 2014

Först inskickad som uppfyllde QC-kriterierna

4 mars 2014

Första postat (Uppskatta)

5 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 juli 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2016

Senast verifierad

1 juni 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ML19070

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