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

25. juli 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

321

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Bulgarien
      • Plovdiv, Bulgarien
        • Study site 01
      • Plovdiv, Bulgarien
        • Study Site 06
      • Sofia, Bulgarien
        • Study Site 02
      • Sofia, Bulgarien
        • Study Site 04
      • Sofia, Bulgarien
        • Study Site 07
      • Stara Zagora, Bulgarien
        • Study Site 05
      • Varna, Bulgarien
        • Study Site 03
  • Canada
    • Quebec
      • Rimouski, Quebec, Canada
        • Study Site 02
      • St-Jérôme, Quebec, Canada
        • Study site 01
  • Den Russiske Føderation
      • Kemerovo, Den Russiske Føderation
        • Study Site 08
      • Kemerovo, Den Russiske Føderation
        • Study site 11
      • Kursk, Den Russiske Føderation
        • Study Site 04
      • Moscow, Den Russiske Føderation
        • Study Site 03
      • Moscow, Den Russiske Føderation
        • Study Site 07
      • Moscow, Den Russiske Føderation
        • Study site 10
      • Omsk, Den Russiske Føderation
        • Study Site 05
      • Saratov, Den Russiske Føderation
        • Study site 09
      • Smolensk, Den Russiske Føderation
        • Study Site 06
      • Tomsk, Den Russiske Føderation
        • Study site 01
      • Yaroslavl, Den Russiske Føderation
        • Study Site 02
  • Estland
      • Tallinn, Estland
        • Study site 01
  • Forenede Stater
    • Arizona
      • Paradise Valley, Arizona, Forenede Stater, 85253
        • Study Site 07
    • Illinois
      • Springfield, Illinois, Forenede Stater, 62704
        • Study site 01
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Study Site 03
    • New Jersey
      • Clifton, New Jersey, Forenede Stater, 07012
        • Study Site 02
    • South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29406
        • Study Site 04
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38305
        • Study Site 05
    • Texas
      • Houston, Texas, Forenede Stater, 77004
        • Study site 09
      • Katy, Texas, Forenede Stater, 77450
        • Study site 10
  • Litauen
      • Kaunas, Litauen
        • Study site 01
      • Vilnus, Litauen
        • Study Site 02
  • Mexico
      • Chihuahua, Mexico
        • Study Site 02
      • Distrito Federal, Mexico
        • Study Site 03
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • Study Site 05
      • Mexico, Distrito Federal, Mexico
        • Study Site 08
    • Guanajuato
      • Leon, Guanajuato, Mexico
        • Study Site 06
  • Polen
      • Bialystok, Polen
        • Study Site 08
      • Bydgoszcz, Polen
        • Study Site 05
      • Elblag, Polen
        • Study site 10
      • Gdynia, Polen
        • Study Site 04
      • Katowice, Polen
        • Study Site 02
      • Krakow, Polen
        • Study Site 03
      • Krakow, Polen
        • Study Site 06
      • Poznan, Polen
        • Study site 09
      • Warszawa, Polen
        • Study site 01
      • Warszawa, Polen
        • Study Site 07
  • Serbien
      • Belgrade, Serbien
        • Study site 01
      • Belgrade, Serbien
        • Study Site 02
      • Belgrade, Serbien
        • Study Site 04
      • Niska Banja, Serbien
        • Study Site 03
  • Slovakiet
      • Bratislava, Slovakiet
        • Study Site 03
      • Kosice - Saca, Slovakiet
        • Study Site 04
      • Lucenec, Slovakiet
        • Study Site 05
      • Povazska Bystrica, Slovakiet
        • Study Site 02
      • Rimavska Sobota, Slovakiet
        • Study site 01
  • Tjekkiet
      • Bruntal, Tjekkiet
        • Study Site 03
      • Ostrava, Tjekkiet
        • Study Site 05
      • Praha, Tjekkiet
        • Study site 01
      • Praha, Tjekkiet
        • Study Site 04
      • Praha, Tjekkiet
        • Study Site 08
      • Praha, Tjekkiet
        • Study site 09
      • Uherske Hradiste, Tjekkiet
        • Study Site 02
      • Uherske Hradiste, Tjekkiet
        • Study Site 07
      • Zlin, Tjekkiet
        • Study Site 06
  • Tyskland
      • Berlin, Tyskland
        • Study Site 03
      • Frankfurt, Tyskland
        • Study Site 04
      • Muenchen, Tyskland
        • Study Site 06
      • Ratingen, Tyskland
        • Study Site 02
      • Zerbst, Tyskland
        • Study site 01
  • Ukraine
      • Donetsk, Ukraine
        • Study Site 08
      • Kharkiv, Ukraine
        • Study site 01
      • Kharkiv, Ukraine
        • Study Site 02
      • Kyiv, Ukraine
        • Study Site 03
      • Kyiv, Ukraine
        • Study Site 04
      • Vinnytsia, Ukraine
        • Study Site 05
      • Vinnytsia, Ukraine
        • Study Site 06
      • Vinnytsia, Ukraine
        • Study Site 07
      • Zaporizhzhia, Ukraine
        • Study site 09
  • Ungarn
      • Balatonfüred, Ungarn
        • Study Site 03
      • Budapest, Ungarn
        • Study Site 02
      • Budapest, Ungarn
        • Study Site 04
      • Budapest, Ungarn
        • Study Site 05
      • Gyula, Ungarn
        • Study Site 06
      • Veszprem, Ungarn
        • Study site 01

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dose Level 1 Tregalizumab
25mg Tregalizumab s.c. weekly
Medicin: Tregalizumab
humanized anti-CD4 mAb
Andre navne:
  • BT061
Eksperimentel: Dose Level 2 Tregalizumab
100mg Tregalizumab s.c. weekly
Medicin: Tregalizumab
humanized anti-CD4 mAb
Andre navne:
  • BT061
Eksperimentel: Dose Level 3 Tregalizumab
200mg Tregalizumab s.c. weekly
Medicin: Tregalizumab
humanized anti-CD4 mAb
Andre navne:
  • BT061
Placebo komparator: Placebo
Placebo s.c. weekly
Medicin: Placebo
identical end formulation buffer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pharmacokinetics
Tidsramme: 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.
Tidsramme: up to 48 weeks
up to 48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biotest

Samarbejdspartnere

AbbVie

Efterforskere

  • Ledende efterforsker: Ronald van Vollenhoven, Prof. MD, Karolinska Universitetssjukhuset, Solna

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. juli 2015

Datoer for studieregistrering

Først indsendt

17. november 2013

Først indsendt, der opfyldte QC-kriterier

2. december 2013

Først opslået (Skøn)

3. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 986_TREAT 2b
  • 2013-000114-38 (EudraCT nummer)
  • BT986 (Anden identifikator: Biotest AG)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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