Clinical trial • Phase IV • Immunology

Adalimumab for Rheumatoid arthritis

Phase IV trial of Adalimumab for Rheumatoid arthritis. open-label, none/not specified-controlled, adaptive. 60 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Rheumatoid arthritis
Trial Stage
Phase IV
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
03-07-2024
First CTIS Authorization Date
20-09-2024

Trial design

open-label, none/not specified-controlled, adaptive Phase IV trial across 8 sites in France.

Open Label
Yes
Comparator
None/Not specified
Adaptive
True, Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months. Time between injections will be increased every 3 months by 50% if no disease flare is clinically detected; in case of disease flare adalimumab will be re-escalated to the previous step until remission is achieved again.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
60
Trial Duration For Participant
450

Eligibility

Recruits 60 No vulnerable population selected. Informed consent must be signed by the patient after information; incapacity or refusal to understand/sign informed consent excludes participation. Patients deprived of liberty or under guardianship/curatorship are explicitly excluded. There is no mention of assent for minors (trial includes adults >18 only)..

Pregnancy Exclusion
Existing pregnancy, lactation, or intended pregnancy within the next 15 months
Vulnerable Population
No vulnerable population selected. Informed consent must be signed by the patient after information; incapacity or refusal to understand/sign informed consent excludes participation. Patients deprived of liberty or under guardianship/curatorship are explicitly excluded. There is no mention of assent for minors (trial includes adults >18 only).

Inclusion criteria

  • {"criterion_text":"- Patient over 18 years of age\n- Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria\n- Remission according to DAS28<2.6 for at least 6 months\n- Patients with ongoing adalimumab treatment for at least 6 months. the patient according to one the following 2 strategies: - (ADA 40 mg every other week) according to the standard regimen OR - ADA 40 mg every 3 week\n- Affiliated person or beneficiary of a social security scheme\n- Informed consent signed by the patient after information\n- A negative highly sensitive pregnancy test for women of Childbearing Potential"}

Exclusion criteria

  • {"criterion_text":"- Incapacity or refusal to understand and / or sign informed consent to participate in the study\n- Existing pregnancy, lactation, or intended pregnancy within the next 15 months\n- Fibromyalgia associated to RA\n- Any dose of prednisone for RA treatment 6 months before inclusion\n- Patient deprived of liberty or patient under guardianship or curatorship"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- To assess the primary objective of the study, a regression analysis is necessary to characterize the relationship between i) the risk of RA flare and ii) adalimumab trough concentrations. RA flare-up : 1/ a DAS28 that increase above 2.6 for patient previously in remission (DAS28≤2.6) and a DAS28 increase (∆DAS28) of 0.6 or greater for patients with low disease activity (2.6","definition_or_measurement_approach":"Regression analysis of the relationship between risk of RA flare and adalimumab trough concentrations. RA flare defined as: DAS28 increase above 2.6 for patients previously in remission (DAS28≤2.6), and a DAS28 increase (∆DAS28) of 0.6 or greater for patients with low disease activity."}

Secondary endpoints

  • {"endpoint_text":"- Presence of anti-adalimumab antibodies will be measured at each visit and at each disease flare. Tolerance will be actively collected at each study visit with an emphasis on any type of infection. All patients will note every infection to a booklet to reduce the memorisation bias.","definition_or_measurement_approach":"Anti-adalimumab antibodies measured at each visit and at each disease flare. Tolerance (safety) actively collected at each study visit, with emphasis on infections; patients will record every infection in a booklet to reduce recall bias."}

Recruitment

Planned Sample Size
60
Recruitment Window Months
36
Consent Approach
Informed consent must be signed by the patient after being informed (ICF present). Incapacity or refusal to understand/sign informed consent excludes participation. Subject information and informed consent form documents are provided. No assent procedures (trial restricted to adults >18).

Geography

Total Number Of Sites
8
Total Number Of Participants
60

France

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
09-12-2025
Processing Time Days
462
Number Of Sites
8
Number Of Participants
60

Sites

Site Name
Centre Hospitalier Departemental Vendee
Department Name
Rhumatologie
Contact Person Name
Grégoire CORMIER
Contact Person Email
gregoire.cormier@ght85.fr
Site Name
Hopitaux Universitaires Pitie Salpetriere
Department Name
Rhumatologie
Contact Person Name
Bruno FAUTREL
Contact Person Email
bruno.fautrel@aphp.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Rhumatologie
Contact Person Name
Denis MULLEMAN
Contact Person Email
denis.mulleman@univ-tours.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Rhumatologie
Contact Person Name
Tristan PASCART
Contact Person Email
pascart.tristant@ghicl.net
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Rhumatologie
Contact Person Name
Hubert MAROTTE
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Rhumatologie
Contact Person Name
Yves-Marie PERS
Contact Person Email
ym-pers@chu-montpellier.fr
Site Name
CLINIQUE DE L INFIRMERIE PROTESTANTE
Department Name
Rhumatologie
Contact Person Name
André BASCH
Contact Person Email
andcroro@gmail.com
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Rhumatologie
Contact Person Name
Jean-Hugues SALMON
Contact Person Email
jhsalmon@chu-reims.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Saint Etienne
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Humira 40 mg solution for injection in pre-filled syringe
Active Substance
Adalimumab
Modality
Monoclonal antibody
Routes Of Administration
Cutaneous use (subcutaneous injection)
Route
Subcutaneous injection
Authorisation Status
Authorised (marketing authorisation EU/1/03/256/002)
Starting Dose
ADA 40 mg every other week
Dose Levels
40 mg every other week; 40 mg every 3 weeks; progressive spacing with intervals increased by 50% every 3 months if no flare
Frequency
Every other week or every 3 weeks; intervals increased by 50% every 3 months if no flare
Maximum Dose
40 mg
Dose Escalation Increase
Initial: 40 mg every other week (or 40 mg every 3 weeks); subsequent intervals increased by 50% every 3 months if no disease flare
Combination Treatment
Yes

Related trials

Other published trials that may interest you.