Clinical trial • Phase III • Immunology
ABATACEPT for Rheumatoid arthritis
Phase III trial of ABATACEPT for Rheumatoid arthritis.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Rheumatoid arthritis
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 08-12-2023
- First CTIS Authorization Date
- 26-01-2024
Trial design
Randomised, abatacept (test; active substance: abatacept; subcutaneous solution for injection; max daily dose listed as 125 mg in record) versus adalimumab (humira 40 mg solution for injection in pre-filled syringe; active substance: adalimumab; subcutaneous; 40 mg specified). both given on background methotrexate. specific schedules not stated in the ctis record.-controlled Phase III trial across 19 sites in Czechia, France, Germany and others.
- Randomised
- Yes
- Comparator
- Abatacept (test; active substance: ABATACEPT; subcutaneous solution for injection; max daily dose listed as 125 mg in record) versus Adalimumab (Humira 40 mg solution for injection in pre-filled syringe; active substance: ADALIMUMAB; subcutaneous; 40 mg specified). Both given on background methotrexate. Specific schedules not stated in the CTIS record.
- Biomarker Stratified
- True, biomarker: SE HLA Class II risk alleles ("Shared Epitope") — primary analyses focused on SE+ subset (SE+) and whole population included as additional strata
- Target Sample Size
- 259
- Trial Duration For Participant
- 728
Eligibility
Recruits 259 Vulnerable population selected in the record. Subject information and informed consent form documents are available (L1_SIS and ICF documents listed), but no detailed description of consent/assent handling for vulnerable participants is provided in the record..
- Pregnancy Exclusion
- Women who are breastfeeding
- Vulnerable Population
- Vulnerable population selected in the record. Subject information and informed consent form documents are available (L1_SIS and ICF documents listed), but no detailed description of consent/assent handling for vulnerable participants is provided in the record.
Inclusion criteria
- {"criterion_text":"- Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months prior to screening and satisfied the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some point during the 12-month period"}
- {"criterion_text":"- Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or investigational therapies for RA"}
- {"criterion_text":"- Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX for at least 4 weeks prior to randomization"}
- {"criterion_text":"- Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of normal and are positive for rheumatoid factor (RF) according to central lab testing during screening"}
- {"criterion_text":"- At least a Disease Activity Score 28-joint count calculated using Creactive protein (DAS28-CRP) ≥ 3.2 at screening"}
- {"criterion_text":"- At least 3 tender and at least 3 swollen joints at screening and at randomization."}
Exclusion criteria
- {"criterion_text":"- Women who are breastfeeding"}
- {"criterion_text":"- Current clinical findings or a history of a demyelinating disorder"}
- {"criterion_text":"- 5 or more joints cannot be assessed for tenderness or swelling"}
- {"criterion_text":"- Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's syndrome) or currently active fibromyalgia"}
- {"criterion_text":"- History of or current inflammatory joint disease other than RA (e.g., psoriatic arthritis, gout, reactive arthritis, Lyme disease)"}
- {"criterion_text":"- At risk for tuberculosis"}
- {"criterion_text":"- Recent acute infection"}
- {"criterion_text":"- History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis, osteomyelitis, bronchiectasis)"}
- {"criterion_text":"- History of infection of a joint prosthesis or artificial joint"}
- {"criterion_text":"- History of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis)"}
- {"criterion_text":"- History of primary immunodeficiency"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of SE+ participants meeting ACR50 response at Week 24","definition_or_measurement_approach":"Measured as the proportion of participants positive for the Shared Epitope (SE+) meeting ACR50 response at Week 24."}
Secondary endpoints
- {"endpoint_text":"- Proportion of SE+ participants achieving DAS28-CRP remission (DAS28-CRP < 2.6) at Week 24","definition_or_measurement_approach":"DAS28-CRP remission defined as DAS28-CRP < 2.6 at Week 24 in SE+ participants."}
- {"endpoint_text":"- Proportion of whole study population participants meeting ACR50 response at Week 24","definition_or_measurement_approach":"Measured as the proportion of all randomized participants meeting ACR50 response at Week 24."}
- {"endpoint_text":"- Proportion of SE+ participants achieving CDAI remission (CDAI ≤ 2.8) at Week 24","definition_or_measurement_approach":"CDAI remission defined as CDAI ≤ 2.8 at Week 24 in SE+ participants."}
- {"endpoint_text":"- Mean change from baseline in SE+ participant-reported pain (VAS) at Week 24","definition_or_measurement_approach":"Mean change from baseline in patient-reported pain using a visual analogue scale (VAS) at Week 24 for SE+ participants."}
- {"endpoint_text":"- Proportion of SE+ subset and whole population achieving ACR20/50/70 responses, DAS remission, CDAI remission, SDAI remission over the SBTP and OLTP; mean changes from baseline in DAS28-CRP, CDAI, SDAI over the SBTP and OLTP; mean changes from baseline in the 7 ACR core components over the SBTP and OLTP","definition_or_measurement_approach":"Composite and multiple efficacy measures assessed over the single-blind treatment period (SBTP) and open-label treatment period (OLTP); includes ACR20/50/70, remission criteria (DAS, CDAI, SDAI), and mean changes in core scores."}
- {"endpoint_text":"- Mean change from baseline in SF-36 in SE+ subset and whole population at Week 24 and Week 104 (4 physical and 4 mental subscales and the physical component and mental component summary)","definition_or_measurement_approach":"Mean change from baseline in SF-36 quality-of-life scores assessed at Week 24 and Week 104 for SE+ subset and whole population."}
Recruitment
- Planned Sample Size
- 259
- Recruitment Window Months
- 46
- Consent Approach
- Subject information and informed consent form documents are listed (L1_SIS and ICF documents, redacted versions present). Patient-facing documents are available in multiple languages (documents in PL, DE, FR, IT etc. are present in the record). No further explicit details on assent, age-specific consent handling, or specific consent procedures are provided in the CTIS record.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 141
Czechia
- Latest Decision Or Authorization Date
- 30-01-2024
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- Revmatologicky Ustav
- Department Name
- Oddeleni experimentalni revmatologie
- Principal Investigator Name
- Ladislav Senolt
- Principal Investigator Email
- senolt@revma.cz
- Contact Person Name
- Ladislav Senolt
- Contact Person Email
- senolt@revma.cz
- Site Name
- Revmatologie s.r.o.
- Principal Investigator Name
- Petr Nemec
- Principal Investigator Email
- revmatologie.nemec@seznam.cz
- Contact Person Name
- Petr Nemec
- Contact Person Email
- revmatologie.nemec@seznam.cz
France
- Latest Decision Or Authorization Date
- 26-01-2024
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Département de Rhumatologie
- Principal Investigator Name
- Jacques MOREL
- Principal Investigator Email
- j-morel@chu-montpellier.fr
- Contact Person Name
- Jacques MOREL
- Contact Person Email
- j-morel@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Centre de Rhumatologie
- Principal Investigator Name
- Arnaud CONSTANTIN
- Principal Investigator Email
- constantin.a@chu-toulouse.fr
- Contact Person Name
- Arnaud CONSTANTIN
- Contact Person Email
- constantin.a@chu-toulouse.fr
Germany
- Latest Decision Or Authorization Date
- 30-01-2024
- Number Of Sites
- 5
- Number Of Participants
- 24
Sites
- Site Name
- Klinische Forschung Im Medizinischen Versorgungsalltag GbR
- Department Name
- Rheumatologie
- Principal Investigator Name
- Patrizia Maria Sternad
- Principal Investigator Email
- patrizia.sternad@rheumatologie-welcker.de
- Contact Person Name
- Patrizia Maria Sternad
- Contact Person Email
- patrizia.sternad@rheumatologie-welcker.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Department Innere Medizin Klinik f. Rheumatologie und Klinische Immunologie
- Principal Investigator Name
- Stephanie Finzel
- Principal Investigator Email
- stephanie.finzel@uniklinik-freiburg.de
- Contact Person Name
- Stephanie Finzel
- Contact Person Email
- stephanie.finzel@uniklinik-freiburg.de
- Site Name
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
- Department Name
- Rheumatologie und Autoimmunmedizin
- Principal Investigator Name
- Andrea Everding
- Principal Investigator Email
- everding@hotmail.de
- Contact Person Name
- Andrea Everding
- Contact Person Email
- everding@hotmail.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Medizinische Klinik und Poliklinik III, Klinik f. Onkologie, Haematologie, Immunonkologie u Rheumato
- Principal Investigator Name
- Valentin Schaefer
- Principal Investigator Email
- valentin.schaefer@ukbonn.de
- Contact Person Name
- Valentin Schaefer
- Contact Person Email
- valentin.schaefer@ukbonn.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Department of Rheumatology and Clinical Immunology
- Principal Investigator Name
- Gerd Burmester
- Principal Investigator Email
- gerd.burmester@charite.de
- Contact Person Name
- Gerd Burmester
- Contact Person Email
- gerd.burmester@charite.de
Italy
- Latest Decision Or Authorization Date
- 26-02-2024
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- Rheumatology
- Principal Investigator Name
- Rosario Foti
- Principal Investigator Email
- rosfoti5@gmail.com
- Contact Person Name
- Rosario Foti
- Contact Person Email
- rosfoti5@gmail.com
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Rheumatology
- Principal Investigator Name
- Francesca Bobbio Pallavicini
- Principal Investigator Email
- f.bobbiopallavicini@smatteo.pv.it
- Contact Person Name
- Francesca Bobbio Pallavicini
- Contact Person Email
- f.bobbiopallavicini@smatteo.pv.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Rheumatology
- Principal Investigator Name
- Maria Antonietta D'agostino
- Principal Investigator Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Contact Person Name
- Maria Antonietta D'agostino
- Contact Person Email
- mariaantonietta.dagostino@policlinicogemelli.it
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- Rheumatology
- Principal Investigator Name
- Roberto Gerli
- Principal Investigator Email
- roberto.gerli@unipg.it
- Contact Person Name
- Roberto Gerli
- Contact Person Email
- roberto.gerli@unipg.it
Spain
- Latest Decision Or Authorization Date
- 29-01-2024
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Rheumatology
- Principal Investigator Name
- Francisco Javier Blanco Garcia
- Principal Investigator Email
- fblagar@sergas.es
- Contact Person Name
- Francisco Javier Blanco Garcia
- Contact Person Email
- fblagar@sergas.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Rheumatology
- Principal Investigator Name
- Alejandro Balsa Criado
- Principal Investigator Email
- alejandro.balsa@salud.madrid.org
- Contact Person Name
- Alejandro Balsa Criado
- Contact Person Email
- alejandro.balsa@salud.madrid.org
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Rheumatology
- Principal Investigator Name
- Ricardo Blanco
- Principal Investigator Email
- rblanco@humv.es
- Contact Person Name
- Ricardo Blanco
- Contact Person Email
- rblanco@humv.es
Poland
- Latest Decision Or Authorization Date
- 18-03-2025
- Number Of Sites
- 3
- Number Of Participants
- 70
Sites
- Site Name
- Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
- Principal Investigator Name
- Jan Brzezicki
- Principal Investigator Email
- janisb@poczta.onet.pl
- Contact Person Name
- Jan Brzezicki
- Contact Person Email
- janisb@poczta.onet.pl
- Site Name
- MICS Centrum Medyczne Torun
- Principal Investigator Name
- Piotr Kalmus
- Principal Investigator Email
- p.kalmus@naszlekarz.pl
- Contact Person Name
- Piotr Kalmus
- Contact Person Email
- p.kalmus@naszlekarz.pl
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Reumatologii i Układowych Chorób Tkanki Łącznej
- Principal Investigator Name
- Iwona Dankiewicz-Fares
- Principal Investigator Email
- iwonadankiewiczfares@gmail.com
- Contact Person Name
- Iwona Dankiewicz-Fares
- Contact Person Email
- iwonadankiewiczfares@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Q2 Solutions Europe
- Responsibilities
- Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis
- Name
- Accenture Services Pvt. Ltd.
- Responsibilities
- Pharmacovigilance duties: Medical review and Cases Data Entry; submission administrative support
Third parties
- {"country":"United Kingdom","full_name":"Q2 Solutions Europe","duties_or_roles":"Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis","organisation_type":"Health care"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"submission administrative support","organisation_type":"SME"}
Investigational products
- Investigational Product Name
- Abatacept
- Active Substance
- ABATACEPT
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Maximum Dose
- 125 mg
- Investigational Product Name
- Humira 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: EU/1/03/256/013)
- Maximum Dose
- 40 mg
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.