Clinical trial • Not applicable • Musculoskeletal
ADALIMUMAB for Rheumatoid arthritis
Not applicable trial of ADALIMUMAB for Rheumatoid arthritis.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Rheumatoid arthritis
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 31-01-2024
- First CTIS Authorization Date
- 21-05-2024
Trial design
Randomised, open-label, standard of care arm (continuation of subcutaneous tnfi (adalimumab) per marketing authorisation) versus proactive therapeutic drug monitoring arm; no additional drug comparator or dose/schedule changes specified beyond standard adalimumab treatment.-controlled Not applicable trial in Norway, Sweden, Austria and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard of care arm (continuation of subcutaneous TNFi (adalimumab) per marketing authorisation) versus proactive therapeutic drug monitoring arm; no additional drug comparator or dose/schedule changes specified beyond standard adalimumab treatment.
- Target Sample Size
- 410
- Trial Duration For Participant
- 540
Eligibility
Recruits 410 No vulnerable population selected. Subjects must be ≥18 years and <75 years and "capable of understanding and signing an informed consent form"; consent must be provided by the participant (no assent/parental consent arrangements described)..
- Pregnancy Exclusion
- Pregnancy, or subject considering becoming pregnant during the study period
- Vulnerable Population
- No vulnerable population selected. Subjects must be ≥18 years and <75 years and "capable of understanding and signing an informed consent form"; consent must be provided by the participant (no assent/parental consent arrangements described).
Inclusion criteria
- {"criterion_text":"- A clinical diagnosis of RA\n- ≥ 18 and < 75 years of age at screening\n- On stable therapy with standard dose of a SC TNFi (adalimumab) for a minimum of 3 months and a maximum of 24 months\n- In low disease activity or remission (DAS28-CRP < 3.2) and indication for continuation of treatment according to the treating physician\n- Subject capable of understanding and signing an informed consent form"}
Exclusion criteria
- {"criterion_text":"- Major comorbidities, such as previous malignancies within the last 5 years, uncontrolled diabetes mellitus, severe infections (including HIV), uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4), severe respiratory diseases, demyelinating disease, significant chronic widespread pain syndrome, significant renal or hepatic disease, and/or other diseases or conditions which either contraindicate treatment with SC TNFi or make adherence to the protocol difficult\n- Hypersensitivity to SC TNFi (adalimumab)\n- Pregnancy, or subject considering becoming pregnant during the study period\n- Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers, or other factors that makes adherence to the study protocol difficult\n- Changes in csDMARD co-medication, including dose changes of csDMARD or changes in the dose of corticosteroids within the last 2 months\n- Co-medication with bDMARD, tsDMARD, or other immunosuppressive drugs (excluding csDMARD and corticosteroids ≤ 7.5 mg prednisolone (or equivalent) once daily).\n- Active participation in any other interventional study\n- In need of live vaccines during the study period"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Sustained disease control over the follow-up period of 18 months without flare, with flare defined as either of the following: A combination of an increase in Disease Activity Score using 28 joints- C-reactive protein (DAS28-CRP) ≥ 1.2, or ≥ 0.6 if DAS28-CRP ≥ 3.2, AND 2 swollen joints on examination of 44 joints Consensus between participant and physician that disease flare has occurred, leading to a major change in treatment","definition_or_measurement_approach":"Flare is defined as (1) increase in DAS28-CRP ≥1.2, or ≥0.6 if baseline DAS28-CRP ≥3.2, AND (2) ≥2 swollen joints on examination of 44 joints, plus consensus between participant and physician that a disease flare has occurred leading to a major change in treatment."}
Secondary endpoints
- {"endpoint_text":"- Disease activity at 4, 8, 12, and 18 months","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to disease flare","definition_or_measurement_approach":""}
- {"endpoint_text":"- Number and type of adverse events (AE)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Drug survival, drug consumption, occurrence of ADAb, serum drug levels","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 410
- Recruitment Window Months
- 42
- Consent Approach
- Informed consent must be signed by the participant (subjects must be capable of understanding and signing an informed consent form). Subject information and informed consent forms for adults are provided; documents are available in multiple languages (documents present for Norwegian, Swedish, German, Italian, Romanian and English). No assent/parental consent described (adults only).
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 410
Norway
- Earliest CTIS Part Ii Submission Date
- 19-04-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 691
- Number Of Sites
- 16
- Number Of Participants
- 291
Sites
- Site Name
- St. Olavs Hospital HF
- Department Name
- Revmatologisk avdeling
- Contact Person Name
- Mari Hoff
- Contact Person Email
- mari.hoff@stolav.no
- Number Of Participants
- unknown
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Rheumatology
- Contact Person Name
- Trude Jannecke Bruun
- Contact Person Email
- Trude.jannecke.bruun@unn.no
- Number Of Participants
- unknown
- Site Name
- Revmatismesykehuset AS
- Department Name
- Rhumatology
- Contact Person Name
- Eldri Kveine Strand
- Contact Person Email
- rxekv@revmatismesykehuset.no
- Number Of Participants
- unknown
- Site Name
- Helgelandssykehuset HF
- Department Name
- Internal medicine
- Contact Person Name
- Petya Galabova
- Contact Person Email
- Petya.Stefanova.Galabova@Helgelandssykehuset.no
- Number Of Participants
- unknown
- Site Name
- Martina Hansens Hospital AS
- Department Name
- Rheumatology
- Contact Person Name
- Anne Bull Haaversen
- Contact Person Email
- Anne.Bull.Haaversen@mhh.no
- Number Of Participants
- unknown
- Site Name
- Helse Moere Og Romsdal HF
- Department Name
- jj
- Contact Person Name
- Astrid Blinheim Langhamme
- Contact Person Email
- postmottak@helse-mr.no
- Number Of Participants
- unknown
- Site Name
- Helse Bergen HF
- Department Name
- Rheumatology Department
- Contact Person Name
- Anne Kristine Halse
- Contact Person Email
- Anne-kristine.halse@helse-bergen.no
- Number Of Participants
- unknown
- Site Name
- Haugesund Sanitetsforenings Revmatismesykehus AS
- Department Name
- partment of Rheumatology
- Contact Person Name
- Svanaug Skorpe
- Contact Person Email
- post@hsr.as
- Number Of Participants
- unknown
- Site Name
- Helse Forde HF
- Department Name
- Rheumatologic dept.
- Contact Person Name
- Pawel Francizek Mieni
- Contact Person Email
- post@helse-forde.no
- Number Of Participants
- unknown
- Site Name
- Betanien Hospital
- Department Name
- Department of Rheumatology
- Contact Person Name
- Christine Stillum
- Contact Person Email
- post@betanienhospital.no
- Number Of Participants
- unknown
- Site Name
- Drammen Sykehus
- Department Name
- s
- Contact Person Name
- Filip Skovlund
- Contact Person Email
- postmottak@vestreviken.no
- Number Of Participants
- unknown
- Site Name
- Sorlandet Sykehus HF
- Department Name
- Rheumatology
- Contact Person Name
- Katarzyna Weronika Losinska
- Contact Person Email
- Katarzyna.Weronika.Losinska@sshf.no
- Number Of Participants
- unknown
- Site Name
- Nordlandssykehuset HF
- Department Name
- Department of Rheumatology, Medical clinic
- Contact Person Name
- Sonja Pederse
- Contact Person Email
- postmottak@nordlandssykehuset.no
- Number Of Participants
- unknown
- Site Name
- Ostfold Hospital Trust
- Department Name
- Department of Rheumatology
- Contact Person Name
- Anne Julsrud
- Contact Person Email
- postmottak@so-hf.no
- Number Of Participants
- unknown
- Site Name
- Helse Stavanger HF
- Department Name
- Rheumatology department.
- Contact Person Name
- Kjartan Bryne Stavanger
- Contact Person Email
- Kjartan.bryne@sus.no
- Number Of Participants
- unknown
- Site Name
- Diakonhjemmet Sykehus AS
- Department Name
- Clinic for rheumatology, policlinic and research
- Contact Person Name
- Ingrdid Jyssum
- Contact Person Email
- Ingrid.Jyssum@diakonsyk.no
- Number Of Participants
- unknown
Sweden
- Earliest CTIS Part Ii Submission Date
- 26-04-2024
- Latest Decision Or Authorization Date
- 06-03-2025
- Processing Time Days
- 315
- Number Of Sites
- 2
- Number Of Participants
- 40
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- ME Gastro, Hud, Reuma, Rheumatology Unit Department of Medicine
- Contact Person Name
- Katerina Aikaterini Chatzidionysiou
- Contact Person Email
- aikaterini.chatzidionysiou@ki.se
- Number Of Participants
- unknown
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Clinical Trial Unit, Rheumatology, Sahlgrenska University Hospital, Grona Straket 16
- Contact Person Name
- Anna-Karin Hultgård Ekwall
- Contact Person Email
- koordinator.reuma@vgregion.se
- Number Of Participants
- unknown
Austria
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 139
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Division of Rheumatology
- Contact Person Name
- Helga Lechner-Radner
- Contact Person Email
- helga.lechner@meduniwien.ac.at
- Number Of Participants
- unknown
Romania
- Earliest CTIS Part Ii Submission Date
- 01-07-2024
- Latest Decision Or Authorization Date
- 10-03-2025
- Processing Time Days
- 253
- Number Of Sites
- 1
- Number Of Participants
- 30
Sites
- Site Name
- Centrul Clinic De Boli Reumatismale Dr. Ion Stoia
- Department Name
- Clinical Centre for Rheumatic Diseases
- Contact Person Name
- Catalin Codreanu
- Contact Person Email
- catalin.codreanu@reumatologiedrstoia.ro
- Number Of Participants
- unknown
Italy
- Earliest CTIS Part Ii Submission Date
- 05-08-2025
- Latest Decision Or Authorization Date
- 12-09-2025
- Processing Time Days
- 39
- Number Of Sites
- 1
- Number Of Participants
- 19
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Division of Rheumatology and Clinical Immunology
- Contact Person Name
- Elisa Gremese
- Contact Person Email
- elisa.gremese@hunimed.eu
- Number Of Participants
- unknown
Sponsor
Primary sponsor
- Full Name
- Diakonhjemmet Sykehus AS
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Third parties
- {"country":"Norway","full_name":"Oslo University Hospital HF","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Norway","full_name":"Oslo University Hospital HF","duties_or_roles":"Monitoring","organisation_type":"Hospital/Clinic/Other health care facility"}
Co-sponsors
- Medical University Of Vienna
- Karolinska University Hospital
- University Of Medicine And Pharmacy Carol Davila Bucharest
- Humanitas Mirasole S.p.A.
Investigational products
- Investigational Product Name
- Yuflyma 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Yuflyma 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hyrimoz 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hyrimoz 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hefiya 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hefiya 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 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
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Humira 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Idacio 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Idacio 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hulio 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hulio 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- AMGEVITA 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- AMGEVITA 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hukyndra 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Hukyndra 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Libmyris 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Imraldi 40 mg solution for injection in pre-filled pen
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
- Investigational Product Name
- Imraldi 40 mg solution for injection in pre-filled syringe
- Active Substance
- ADALIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Starting Dose
- 40 mg
- Maximum Dose
- 40 mg
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