Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis (986)

25 luglio 2017 aggiornato da: Biotest

A 24-week Phase IIb, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Tregalizumab (BT061) in Combination With Methotrexate in the Treatment of Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Alone, Followed by a 24-week Extension Phase: T Cell REgulating Arthritis Trial 2b (TREAT 2b)

The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone.

The overall study duration is 24 weeks followed by a 24 week extension phase.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The planned clinical study 986 (TREAT 2b) is a 24-week study in patients with Active rheumatoid arthritis (RA) who have had an inadequate response to Methotrexate (MTX) alone. The main phase of this study is followed by a 24-week extension phase for subjects meeting the respective entry criteria. Patients will be randomized to one of three different Active treatment groups or Placebo. The primary efficacy variable is the proportion of subjects with an ACR20 response after 12 weeks of double blinded treatment with the study medication based on observed cases in the FAS.

At Week 12, all subjects who had a minimum improvement of at least 20% (from baseline) in their tender joint count (TJC) and swollen joint count (SJC) continued on the same treatment. Subjects who had not demonstrated an improvement of at least 20% of TJC and SJC were assessed as non-responders. Non-responders who received placebo were randomized to an active treatment dose in a blinded manner. Non-responders who received active treatment were rolled up to the next highest dose in a blinded manner, apart from those already on the highest dose. These subjects remained on the highest dose.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

321

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Bulgaria
      • Plovdiv, Bulgaria
        • Study site 01
      • Plovdiv, Bulgaria
        • Study site 06
      • Sofia, Bulgaria
        • Study site 02
      • Sofia, Bulgaria
        • Study site 04
      • Sofia, Bulgaria
        • Study Site 07
      • Stara Zagora, Bulgaria
        • Study site 05
      • Varna, Bulgaria
        • Study site 03
  • Canada
    • Quebec
      • Rimouski, Quebec, Canada
        • Study site 02
      • St-Jérôme, Quebec, Canada
        • Study site 01
  • Cechia
      • Bruntal, Cechia
        • Study site 03
      • Ostrava, Cechia
        • Study site 05
      • Praha, Cechia
        • Study site 01
      • Praha, Cechia
        • Study site 04
      • Praha, Cechia
        • Study Site 08
      • Praha, Cechia
        • Study site 09
      • Uherske Hradiste, Cechia
        • Study site 02
      • Uherske Hradiste, Cechia
        • Study Site 07
      • Zlin, Cechia
        • Study site 06
  • Estonia
      • Tallinn, Estonia
        • Study site 01
  • Federazione Russa
      • Kemerovo, Federazione Russa
        • Study Site 08
      • Kemerovo, Federazione Russa
        • Study site 11
      • Kursk, Federazione Russa
        • Study site 04
      • Moscow, Federazione Russa
        • Study site 03
      • Moscow, Federazione Russa
        • Study Site 07
      • Moscow, Federazione Russa
        • Study site 10
      • Omsk, Federazione Russa
        • Study site 05
      • Saratov, Federazione Russa
        • Study site 09
      • Smolensk, Federazione Russa
        • Study site 06
      • Tomsk, Federazione Russa
        • Study site 01
      • Yaroslavl, Federazione Russa
        • Study site 02
  • Germania
      • Berlin, Germania
        • Study site 03
      • Frankfurt, Germania
        • Study site 04
      • Muenchen, Germania
        • Study site 06
      • Ratingen, Germania
        • Study site 02
      • Zerbst, Germania
        • Study site 01
  • Lituania
      • Kaunas, Lituania
        • Study site 01
      • Vilnus, Lituania
        • Study site 02
  • Messico
      • Chihuahua, Messico
        • Study site 02
      • Distrito Federal, Messico
        • Study site 03
    • Distrito Federal
      • Mexico, Distrito Federal, Messico
        • Study site 05
      • Mexico, Distrito Federal, Messico
        • Study Site 08
    • Guanajuato
      • Leon, Guanajuato, Messico
        • Study site 06
  • Polonia
      • Bialystok, Polonia
        • Study Site 08
      • Bydgoszcz, Polonia
        • Study site 05
      • Elblag, Polonia
        • Study site 10
      • Gdynia, Polonia
        • Study site 04
      • Katowice, Polonia
        • Study site 02
      • Krakow, Polonia
        • Study site 03
      • Krakow, Polonia
        • Study site 06
      • Poznan, Polonia
        • Study site 09
      • Warszawa, Polonia
        • Study site 01
      • Warszawa, Polonia
        • Study Site 07
  • Serbia
      • Belgrade, Serbia
        • Study site 01
      • Belgrade, Serbia
        • Study site 02
      • Belgrade, Serbia
        • Study site 04
      • Niska Banja, Serbia
        • Study site 03
  • Slovacchia
      • Bratislava, Slovacchia
        • Study site 03
      • Kosice - Saca, Slovacchia
        • Study site 04
      • Lucenec, Slovacchia
        • Study site 05
      • Povazska Bystrica, Slovacchia
        • Study site 02
      • Rimavska Sobota, Slovacchia
        • Study site 01
  • Stati Uniti
    • Arizona
      • Paradise Valley, Arizona, Stati Uniti, 85253
        • Study Site 07
    • Illinois
      • Springfield, Illinois, Stati Uniti, 62704
        • Study site 01
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68516
        • Study site 03
    • New Jersey
      • Clifton, New Jersey, Stati Uniti, 07012
        • Study site 02
    • South Carolina
      • North Charleston, South Carolina, Stati Uniti, 29406
        • Study site 04
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38305
        • Study site 05
    • Texas
      • Houston, Texas, Stati Uniti, 77004
        • Study site 09
      • Katy, Texas, Stati Uniti, 77450
        • Study site 10
  • Ucraina
      • Donetsk, Ucraina
        • Study Site 08
      • Kharkiv, Ucraina
        • Study site 01
      • Kharkiv, Ucraina
        • Study site 02
      • Kyiv, Ucraina
        • Study site 03
      • Kyiv, Ucraina
        • Study site 04
      • Vinnytsia, Ucraina
        • Study site 05
      • Vinnytsia, Ucraina
        • Study site 06
      • Vinnytsia, Ucraina
        • Study Site 07
      • Zaporizhzhia, Ucraina
        • Study site 09
  • Ungheria
      • Balatonfüred, Ungheria
        • Study site 03
      • Budapest, Ungheria
        • Study site 02
      • Budapest, Ungheria
        • Study site 04
      • Budapest, Ungheria
        • Study site 05
      • Gyula, Ungheria
        • Study site 06
      • Veszprem, Ungheria
        • Study site 01

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 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. Subject demonstrates active RA according to the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) classification criteria for RA with functional class I-III for ≥6 months.
  2. Subject receives oral or parenteral MTX treatment for ≥12 weeks (overall), with an unchanged mode of application and stable MTX dose of ≥15 mg per week (or ≥12.5 mg per week in case of MTX intolerance), but no more than the highest locally approved dose for RA, for ≥8 weeks prior to baseline. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons. If applicable, the dose of folic acid must be unchanged for ≥8 weeks prior to baseline.
  3. Subject meets the following two criteria at both screening and baseline: - At least 6 swollen joints at 28-joint assessment. - At least 6 tender joints at 28-joint assessment.
  4. Subject has an erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) above the upper limit of normal (ULN) at screening. These tests may be repeated once during the screening period at the discretion of the investigator.
  5. Subject is ≥18 and ≤75 years of age.
  6. Subject has a body mass index ≥18 and ≤35 kg/m².
  7. Subject receives treatment with corticosteroids ≤10 mg prednisone equivalent, stable for at least 4 weeks prior to baseline and during the study, if applicable.
  8. Subject receives treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable for at least 2 weeks prior to baseline and during the study, if applicable.
  9. Female subjects of childbearing potential: has both a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
  10. Subject is judged to be in good general health as determined by the investigator based upon the results of medical history, laboratory profile, physical examination, chest X-ray (within 3 months before screening date is acceptable), and 12-lead electrocardiogram (ECG).
  11. Subject has a cluster of differentiation 4 (CD4) cell count of > 400/µl at screening.

Exclusion Criteria:

  1. Subject has previous exposure to any systemic biologic therapy (e.g., etanercept, adalimumab, rituximab, abatacept, tocilizumab), to Janus kinase (JAK) or spleen tyrosine kinase (SYK) inhibitors, or to Tregalizumab. Previous treatment with an anti-TNF agent is allowed only, if all of the following criteria apply: - treatment was stopped for reasons other than lack of efficacy or adverse events (AEs) - treatment was stopped at least 12 weeks or five half-lives of the compound prior to baseline (whichever is longer), and - the treatment period did not exceed 6 weeks.
  2. Subject received treatment with conventional disease-modifying anti-rheumatic drugs (DMARDs) apart from MTX in the 12 weeks prior to baseline, and for DMARD leflunomide in the 24 weeks prior to baseline (except where specific leflunomide wash-out procedures were completed, following applicable guidelines).
  3. Subject has been treated with intra-articular or parenteral administration of corticosteroids in the 4 weeks prior to baseline. Inhaled corticosteroids for stable medical conditions are allowed.
  4. Subject has undergone joint surgery in the 12 weeks prior to baseline (at joints to be assessed within the study) or has undergone major surgery (e.g., abdominal surgery) in the 8 weeks prior to baseline.
  5. Subject has a history of acute inflammatory joint disease of an origin other than RA or subject has any other rheumatic disease other than RA (e.g., mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, fibromyalgia, systemic lupus erythematosus or any arthritis with onset prior to age 17 years). However, subjects may have secondary Sjögren's syndrome.

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Dose Level 1 Tregalizumab
25mg Tregalizumab s.c. weekly
Droga: Tregalizumab
humanized anti-CD4 mAb
Altri nomi:
  • BT061
Sperimentale: Dose Level 2 Tregalizumab
100mg Tregalizumab s.c. weekly
Droga: Tregalizumab
humanized anti-CD4 mAb
Altri nomi:
  • BT061
Sperimentale: Dose Level 3 Tregalizumab
200mg Tregalizumab s.c. weekly
Droga: Tregalizumab
humanized anti-CD4 mAb
Altri nomi:
  • BT061
Comparatore placebo: Placebo
Placebo s.c. weekly
Droga: Placebo
identical end formulation buffer

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX
Lasso di tempo: Week 12

The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.

The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.
Week 12

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Proportions of Subjects With an ACR 20 Response.
Lasso di tempo: Week 24
Week 24
Proportions of Subjects With an ACR 50 & 70 Response.
Lasso di tempo: Week 12 & Week 24
Week 12 & Week 24
Proportions of Subjects With an Disease Activity Score DAS28 <2.6
Lasso di tempo: Week 12 & Week 24
Week 12 & Week 24
Proportions of Subjects With Low Disease Activity DAS28 ≤3.2
Lasso di tempo: Week 12 & Week 24
Week 12 & Week 24
ACR Score
Lasso di tempo: up to 48 weeks
up to 48 weeks
Simple Disease Activity Index [SDAI] ≤11
Lasso di tempo: week 12 & 24
week 12 & 24
Clinical Disease Activity Index [CDAI] ≤10
Lasso di tempo: week 12 & 24
week 12 & 24
DAS28
Lasso di tempo: up to 48 weeks
up to 48 weeks
EULAR Response
Lasso di tempo: up to 48 weeks
up to 48 weeks
ACR Score Individual Components
Lasso di tempo: up to 48 weeks
up to 48 weeks
DAS28 Score Individual Components
Lasso di tempo: up to 48 weeks
up to 48 weeks

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pharmacokinetics
Lasso di tempo: up to 48 weeks
AUC, Cmax, Tmax at baseline, and at Week (W) 2/Visit (V) 4, W4/V5, W8/V7, W12/V8, W24/V10, W3/V122, W48 (end of Treatment [EoT]/ early termination ET), and at follow-up (post EoT/post ET).
up to 48 weeks
Evaluation of Safety, Patient Reported Outcomes & Blood Tests.
Lasso di tempo: up to 48 weeks
up to 48 weeks

Collaboratori e investigatori

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

Sponsor

Biotest

Collaboratori

AbbVie

Investigatori

  • Investigatore principale: Ronald van Vollenhoven, Prof. MD, Karolinska Universitetssjukhuset, Solna

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

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 ottobre 2013

Completamento primario (Effettivo)

1 luglio 2015

Completamento dello studio (Effettivo)

1 luglio 2015

Date di iscrizione allo studio

Primo inviato

17 novembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

2 dicembre 2013

Primo Inserito (Stima)

3 dicembre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 agosto 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 luglio 2017

Ultimo verificato

1 luglio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 986_TREAT 2b
  • 2013-000114-38 (Numero EudraCT)
  • BT986 (Altro identificatore: Biotest AG)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

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 .

Prove cliniche su Tregalizumab

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Armenia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi