NL-OMON54205招募中不适用
Immune Related Rheumatological Adverse Events. Data collection from patients with cancer to evaluate rheumatological adverse events in patients treated with immune-checkpoint inhibitors. - IRRAE-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 495
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
- •- 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
排除标准
- •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
- •- Pregnancy and/or breastfeeding (in female participants of reproductive
- •- 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
- •- Pregnancy and/or breastfeeding (in female participants of reproductive
- •- 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.
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