Demyelinating Risk with TNF Inhibitors versus Other Targeted DMARDs in Rheumatoid Arthritis: A French Nationwide Claims Study (DEMY-TNF)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001021
• Study ID:
  1000001021
• Official title and acronym:
  Demyelinating Risk with TNF Inhibitors versus Other Targeted DMARDs in Rheumatoid Arthritis: A French Nationwide Claims Study (DEMY-TNF)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  This is an active-comparator, new-user cohort study using data from the French National Health Data System (SNDS). The objective of the study is to compare the risk of nervous system demyelinating events in patients with rheumatoid arthritis (RA) initiating TNF inhibitors versus CTLA4-Ig or IL-6 inhibitors as first-line biologic therapy after at least one conventional synthetic DMARD (csDMARD) (target trial emulation (TTE) 1: TNFi vs [CTLA4-Ig or IL-6i]). Secondary objectives are to assess the risk of demyelinating events considering those affecting the central nervous system (CNS) and the peripheral nervous system (PNS) separately, in RA patients initiating treatment with TNF inhibitors versus CTLA4-Ig or IL-6 inhibitors, as first-line biologic therapy after csDMARD (TTE 1: TNFi vs [CTLA4-Ig + IL-6i]).; To compare the risk of nervous system demyelinating events in patients with RA initiating TNF inhibitors versus:; - CTLA4-Ig or IL-6 inhibitors or Janus kinase inhibitors (JAK inhibitors) (TTE 2: TNFi vs [CTLA4-Ig or IL-6i or JAKi]); - CTLA4-Ig (TTE 3: TNFi vs CTLA4-Ig); - IL-6 inhibitors (TTE 4: TNFi vs IL-6i); - JAK inhibitors (TTE 5: TNFi vs JAKi)
• Study status:
  Ongoing

Research institutions and networks

Institutions

Centre de pharmaco-épidémiologie (Paris Pharmacoepidemiology Centre), Assistance Publique, Hôpitaux de Paris

France

Study timelines

Date when funding contract was signed

Planned:01/11/2025

Actual:17/04/2026

Study start date

Planned:01/05/2026

Actual:01/05/2026

Data analysis start date

Planned:30/06/2026

Date of interim report, if expected

Planned:31/12/2026

Date of final study report

Planned:30/06/2027

Sources of funding

Other public funding (e.g. hospital or university)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable