Immune Related Rheumatological Adverse Events. Data collection from patients with cancer to evaluate rheumatological adverse events in patients treated with immune-checkpoint inhibitors.

Recruiting

• Conditions: Rheumatological side effects to therapy; 10003816; 10027655

• Registration Number: NL-OMON54205
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 495

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 (<3 months) completed treatment with ICI therapy (see
M1)
- Development of any R-irAE diagnosed by a physician using established
criteria(CTCAE)

Main cohort M3:
- >=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

- PET-subgroup S2.1:
- Synovial biopsy possible in affected joint

Subgroup S3:
- >=18 yr.
- De novo RA according to ACR/EULAR criteria 2010.

- PET-subgroup S3.1:
- Synovial biopsy possible in affected joint

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

- Subgroup 2.1
- 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.

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified