Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis (986)
25 de julio de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
321
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Berlin, Alemania
- Study site 03
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Frankfurt, Alemania
- Study site 04
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Muenchen, Alemania
- Study site 06
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Ratingen, Alemania
- Study site 02
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Zerbst, Alemania
- Study site 01
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Plovdiv, Bulgaria
- Study site 01
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Plovdiv, Bulgaria
- Study site 06
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Sofia, Bulgaria
- Study site 02
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Sofia, Bulgaria
- Study site 04
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Sofia, Bulgaria
- Study Site 07
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Stara Zagora, Bulgaria
- Study site 05
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Varna, Bulgaria
- Study site 03
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Quebec
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Rimouski, Quebec, Canadá
- Study site 02
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St-Jérôme, Quebec, Canadá
- Study site 01
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Bruntal, Chequia
- Study site 03
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Ostrava, Chequia
- Study site 05
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Praha, Chequia
- Study site 01
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Praha, Chequia
- Study site 04
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Praha, Chequia
- Study Site 08
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Praha, Chequia
- Study site 09
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Uherske Hradiste, Chequia
- Study site 02
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Uherske Hradiste, Chequia
- Study Site 07
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Zlin, Chequia
- Study site 06
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Bratislava, Eslovaquia
- Study site 03
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Kosice - Saca, Eslovaquia
- Study site 04
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Lucenec, Eslovaquia
- Study site 05
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Povazska Bystrica, Eslovaquia
- Study site 02
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Rimavska Sobota, Eslovaquia
- Study site 01
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Arizona
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Paradise Valley, Arizona, Estados Unidos, 85253
- Study Site 07
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Illinois
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Springfield, Illinois, Estados Unidos, 62704
- Study site 01
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Nebraska
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Lincoln, Nebraska, Estados Unidos, 68516
- Study site 03
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New Jersey
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Clifton, New Jersey, Estados Unidos, 07012
- Study site 02
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South Carolina
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North Charleston, South Carolina, Estados Unidos, 29406
- Study site 04
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Tennessee
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Jackson, Tennessee, Estados Unidos, 38305
- Study site 05
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Texas
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Houston, Texas, Estados Unidos, 77004
- Study site 09
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Katy, Texas, Estados Unidos, 77450
- Study site 10
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Tallinn, Estonia
- Study site 01
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Kemerovo, Federación Rusa
- Study Site 08
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Kemerovo, Federación Rusa
- Study site 11
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Kursk, Federación Rusa
- Study site 04
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Moscow, Federación Rusa
- Study site 03
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Moscow, Federación Rusa
- Study Site 07
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Moscow, Federación Rusa
- Study site 10
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Omsk, Federación Rusa
- Study site 05
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Saratov, Federación Rusa
- Study site 09
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Smolensk, Federación Rusa
- Study site 06
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Tomsk, Federación Rusa
- Study site 01
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Yaroslavl, Federación Rusa
- Study site 02
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Balatonfüred, Hungría
- Study site 03
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Budapest, Hungría
- Study site 02
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Budapest, Hungría
- Study site 04
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Budapest, Hungría
- Study site 05
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Gyula, Hungría
- Study site 06
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Veszprem, Hungría
- Study site 01
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Kaunas, Lituania
- Study site 01
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Vilnus, Lituania
- Study site 02
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Chihuahua, México
- Study site 02
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Distrito Federal, México
- Study site 03
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Distrito Federal
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Mexico, Distrito Federal, México
- Study site 05
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Mexico, Distrito Federal, México
- Study Site 08
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Guanajuato
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Leon, Guanajuato, México
- Study site 06
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Bialystok, Polonia
- Study Site 08
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Bydgoszcz, Polonia
- Study site 05
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Elblag, Polonia
- Study site 10
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Gdynia, Polonia
- Study site 04
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Katowice, Polonia
- Study site 02
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Krakow, Polonia
- Study site 03
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Krakow, Polonia
- Study site 06
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Poznan, Polonia
- Study site 09
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Warszawa, Polonia
- Study site 01
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Warszawa, Polonia
- Study Site 07
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Belgrade, Serbia
- Study site 01
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Belgrade, Serbia
- Study site 02
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Belgrade, Serbia
- Study site 04
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Niska Banja, Serbia
- Study site 03
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Donetsk, Ucrania
- Study Site 08
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Kharkiv, Ucrania
- Study site 01
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Kharkiv, Ucrania
- Study site 02
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Kyiv, Ucrania
- Study site 03
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Kyiv, Ucrania
- Study site 04
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Vinnytsia, Ucrania
- Study site 05
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Vinnytsia, Ucrania
- Study site 06
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Vinnytsia, Ucrania
- Study Site 07
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Zaporizhzhia, Ucrania
- Study site 09
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 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.
- 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.
- 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.
- 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.
- Subject is ≥18 and ≤75 years of age.
- Subject has a body mass index ≥18 and ≤35 kg/m².
- Subject receives treatment with corticosteroids ≤10 mg prednisone equivalent, stable for at least 4 weeks prior to baseline and during the study, if applicable.
- 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.
- Female subjects of childbearing potential: has both a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline.
- 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).
- Subject has a cluster of differentiation 4 (CD4) cell count of > 400/µl at screening.
Exclusion Criteria:
- 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.
- 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).
- 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.
- 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.
- 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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Dose Level 1 Tregalizumab
25mg Tregalizumab s.c. weekly
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humanized anti-CD4 mAb
Otros nombres:
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Experimental: Dose Level 2 Tregalizumab
100mg Tregalizumab s.c. weekly
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humanized anti-CD4 mAb
Otros nombres:
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Experimental: Dose Level 3 Tregalizumab
200mg Tregalizumab s.c. weekly
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humanized anti-CD4 mAb
Otros nombres:
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Comparador de placebos: Placebo
Placebo s.c. weekly
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identical end formulation buffer
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX
Periodo de tiempo: Week 12
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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
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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Proportions of Subjects With an ACR 20 Response.
Periodo de tiempo: Week 24
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Week 24
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Proportions of Subjects With an ACR 50 & 70 Response.
Periodo de tiempo: Week 12 & Week 24
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Week 12 & Week 24
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Proportions of Subjects With an Disease Activity Score DAS28 <2.6
Periodo de tiempo: Week 12 & Week 24
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Week 12 & Week 24
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Proportions of Subjects With Low Disease Activity DAS28 ≤3.2
Periodo de tiempo: Week 12 & Week 24
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Week 12 & Week 24
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ACR Score
Periodo de tiempo: up to 48 weeks
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up to 48 weeks
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Simple Disease Activity Index [SDAI] ≤11
Periodo de tiempo: week 12 & 24
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week 12 & 24
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Clinical Disease Activity Index [CDAI] ≤10
Periodo de tiempo: week 12 & 24
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week 12 & 24
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DAS28
Periodo de tiempo: up to 48 weeks
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up to 48 weeks
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EULAR Response
Periodo de tiempo: up to 48 weeks
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up to 48 weeks
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ACR Score Individual Components
Periodo de tiempo: up to 48 weeks
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up to 48 weeks
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DAS28 Score Individual Components
Periodo de tiempo: up to 48 weeks
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up to 48 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pharmacokinetics
Periodo de tiempo: up to 48 weeks
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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).
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up to 48 weeks
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Evaluation of Safety, Patient Reported Outcomes & Blood Tests.
Periodo de tiempo: up to 48 weeks
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up to 48 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2013
Finalización primaria (Actual)
1 de julio de 2015
Finalización del estudio (Actual)
1 de julio de 2015
Fechas de registro del estudio
Enviado por primera vez
17 de noviembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
2 de diciembre de 2013
Publicado por primera vez (Estimar)
3 de diciembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
25 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 986_TREAT 2b
- 2013-000114-38 (Número EudraCT)
- BT986 (Otro identificador: Biotest AG)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Tregalizumab
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T-Balance Therapeutics GmbHTerminadoAsma alérgica | Alergia al ácaro del polvo domésticoAlemania