Rheumatological side effects to therapy
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 8 Cohorts in study: M1-3, S1-3, S2.1 and S3.1: Main cohort M1/Subgroup S1: - >=18 yr. - Diagnosed with any oncological disease - Starting with ICI therapy (ICI therapy defined as treatment with anti-PD1, anti-PDL1, anti-CTLA-4 or anti-Lag3, either in mono- or combination therapy) Main cohort M2: - >=18 yr. - Diagnosed with any oncological disease - Current or recently (=18 yr. - Pre-existing rheumatological disease as diagnosed by rheumatologist - Diagnosed with any oncological disease - Initiation with ICI therapy (see M1) Subgroup S2: - Participant in M1 cohort - Specific R-irAE of arthritis in at least one joint - Subgroup S2.1: - Synovial biopsy technically possible in affected joint Subgroup S3: - >=18 yr. - De novo RA according to ACR/EULAR criteria 2010. - PET-subgroup S3.1: - Synovial biopsy technically possible in affected joint
Exclusion criteria
Exclusion criteria: 8 Cohorts in study: M1-3, S1-3, S2.1 and S3.1: Main study cohort M1: - Pre-existing rheumatological disease as diagnosed by a rheumatologist - Previous treatment with ICI therapy Main/substudy cohorts M2/S2/S3: - Any other identified cause of the R-irAE or RA, not being ICI therapy - Previous treatment with ICI therapy Main study cohort M3: - No cohort-specific exclusion criteria - Previous treatment with ICI therapy Subgroup S1: - Pre-existing rheumatological disease - Development of a R-irAE(in these cases switch to M2/S2 cohort possible depending on specific irAE) Subgroup S2: - No cohort specific exclusion criteria beyond M1 criteria - PET group: Research related radiation exposure (cumulative >= 5 mSv) in the year before inclusion - PET group: Pregnancy and/or breastfeeding (in female participants of reproductive potential) - Subgroup S2.1 - Previous local injection, arthroscopy, surgery or other medical intervention on selected arthritic joint for synovial biopsy in the past 1 year - History of joint-replacement surgery of the joint chosen for synovial biopsy. Subgroup S3: - Pre-existing rheumatological disease - Previous or current use of prednisone, disease modifying anti-rheumatic drugs (DMARD*s) or biological treatment (NSAID*s/Paracetamol allowed) Subgroup S3.1: - Research related radiation exposure (cumulative >= 5 mSv) in the year before inclusion - Pregnancy and/or breastfeeding (in female participants of reproductive potential) - Previous local injection, arthroscopy, surgery or other medical intervention on selected arthritic joint for synovial biopsy in the past 1 year - History of joint-replacement surgery of the joint chosen for synovial biopsy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compiling a comprehensive dataset on R-irAE and immune related arthritis, including incidence (expressed as odds-ratio(OR), relative risk (RR) and progression free survival (PFS)), (time to) diagnosis, management of said R-irAE*s including treatment type, duration, intensity and outcomes of both the adverse event itself and functional repercussions. Additional data regarding disease-specific serological markers and general inflammatory serology will be included, as well as quality of life (QOL) evaluations using standardized questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| (Immunohistochemical) phenotype (determined in blood, synovial fluid and synovial tissue) of patients who develop irAE arthritis as compared to those who develop classical RA and to those who do not develop irAE while treated with immunotherapy. Qualitative (and potentially semi-quantitative) evaluation and comparison of whole body 18F-FDG PET-CT imaging in R-irAE arthritis and de novo RA patients to investigate presence and biodistribution of inflammatory activity in joints and other tissues. | — |
Countries
Netherlands
Outcome results
None listed