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An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

11 settembre 2013 aggiornato da: Xian-Janssen Pharmaceutical Ltd.

A Multi-Center, Pre-Marketing Clinical Trial to Evaluate the Efficacy and Safety of Infliximab Treatment on Rheumatoid Arthritis

The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 [DAS 28]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX. DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain. Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 Weeks. Participants will have a follow-up visit on Week 26. Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26. Participants' safety will be assessed throughout the study.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

234

Fase

  • Fase 4

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Participants who have a definitive diagnosis of rheumatoid arthritis (RA) based on the American College of Rheumatology Criteria 1987
  • Participants must have been on Methotrexate (MTX) for 12 weeks at the stable dose for at least 4 weeks
  • Participants using oral corticosteroids, must have been on a stable dose of prednisone less than 10 milligram per day (mg/day) or its equivalent for at least 4 weeks before screening or if currently not using corticosteroids, the participant must not have received corticosteroids for at least 4 weeks before screening
  • Participants with moderate to severe RA (Disease Activity Score [DAS28] greater than 3.2)
  • Male participants shall adopt contraceptive measures during the trial and within 6 months after the completion of trial (such as spermicidal barrier), or their female sexual partners shall agree to adopt effective contraceptive measures during the trial or within 6 months after the completion of trial (such as oral contraceptives, contraceptives for injection, intrauterine device [IUD], or sterilization by surgery); female participants of childbearing potential with negative urine pregnancy test upon enrollment in addition to adopting the said contraceptive measures

Exclusion Criteria:

  • Participant who has a known allergy to human immunoglobulin proteins or other components of infliximab
  • Participant who has a history of receiving infliximab or any other biological preparations
  • Participant who is in stage IV RA evaluated by X-ray
  • Participants suffering from tuberculosis
  • Female participant or male participant's wife who plans to become pregnant during this study and within 6 months after completion of this study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Infliximab + Methotrexate (Moderate RA)
Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
Droga: Infliximab
Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.
Droga: Methotrexate
MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.
Sperimentale: Infliximab + Methotrexate (Severe RA)
Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks.
Droga: Infliximab
Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.
Droga: Methotrexate
MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving American College of Rheumatology Score 20 Percent (ACR20) Response
Lasso di tempo: Week 26
ACR20 is achieved if the participant has 20% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).
Week 26
Percentage of Participants Achieving American College of Rheumatology Score 50 Percent (ACR50) Response
Lasso di tempo: Week 26
ACR50 is achieved if the participant has 50% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).
Week 26
Percentage of Participants Achieving American College of Rheumatology Score 70 Percent (ACR70) Response
Lasso di tempo: Week 26
ACR70 is achieved if the participant has 70% improvement from Baseline in swollen joint count; tender joint count and in at least 3 of the following 5 assessments: participants' assessment of pain; participants' global assessment of disease activity; physician's global assessment of disease activity; participants' assessment of physical function (Health Assessment Questionnaire [HAQ]) and C-reactive protein (CRP).
Week 26

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Swollen Joints Count at Week 26
Lasso di tempo: Baseline and Week 26
Number of swollen joints were determined by examination of 28 joints and identifying when swelling is present. The number of swollen joints was recorded on the joint assessment form at each visit; the swelling was graded on a scale ranging from 0-2 (0=no swelling, 1=swelling, but bony landmarks seen, 2=swelling but bone marks not seen). Participants categorized as Hepatitis B Virus antigen (HBsAb) positive/negative (at least 1 of HbsAg, HBeAg, Anti-HbeAg and Anti-HbcAg were positive or all were negative).
Baseline and Week 26
Change From Baseline in Tender Joints Count at Week 26
Lasso di tempo: Baseline and Week 26
Number of tender joints was determined by examination of 28 joints and identifying when tenderness is present. The number of tender joints was recorded on the joint assessment form at each visit; the tenderness of symptomatic joints was graded on a scale ranging from 0-3 (0=no pain, 1=mild, 2= moderate and 3=severe).
Baseline and Week 26
Change From Baseline in Participant's Pain Visual Analogue Scale (VAS) Score at Week 26
Lasso di tempo: Baseline and Week 26
Participant's pain was assessed on VAS of 0 to 100 mm (0=not at all to 100=extreme pain).
Baseline and Week 26
Change From Baseline in Participants' Global Disease Assessment at Week 26
Lasso di tempo: Baseline and Week 26
Participants scored the overall disease state using VAS of 0-100 mm. Participants might have assessed the Control of their current disease using "0 mm=very good" to "100 mm=very poor" scale.
Baseline and Week 26
Change From Baseline in Physicians' Global Disease Assessment at Week 26
Lasso di tempo: Baseline and Week 26
Physicians scored the overall disease state using VAS of 0-100 mm. Physicians might have assessed the activity of RA using "0=no active RA" to "100=most serious active RA" scale.
Baseline and Week 26
Change From Baseline in Duration of Morning Stiffness at Week 26
Lasso di tempo: Baseline and Week 26
Duration of morning stiffness: Time elapsed in minutes when participant woke up in morning and was able to resume normal activities without stiffness. Increase in stiffness duration from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline and Week 26
Change From Baseline in Health Assessment Questionnaire (HAQ) at Week 26
Lasso di tempo: Baseline and Week 26
The HAQ, a 20-question instrument, assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each area are scored from 0=no difficulty to 3=inability to perform a task in that area.
Baseline and Week 26
Change From Baseline in C-Reactive Protein (CRP) at Week 26
Lasso di tempo: Baseline and Week 26
CRP is a protein found in the blood, the levels of which rise in response to inflammation.
Baseline and Week 26
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 26
Lasso di tempo: Baseline and Week 26
ESR is also called a sedimentation rate or Westergren ESR, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test, and is a non-specific measure of inflammation.
Baseline and Week 26

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Xian-Janssen Pharmaceutical Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2007

Completamento primario (Effettivo)

1 aprile 2008

Completamento dello studio (Effettivo)

1 aprile 2008

Date di iscrizione allo studio

Primo inviato

7 maggio 2009

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2009

Primo Inserito (Stima)

11 maggio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

13 settembre 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2013

Ultimo verificato

1 settembre 2013

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR015460
  • REMICADEART4005

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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