← Back to Search

Biological DMARD

Anti-TNFα continued perioperatively for Rheumatoid Arthritis

Phase 4
Waitlist Available
Led By Mélissa Laflamme, MD, MsC
Research Sponsored by CHU de Quebec-Universite Laval
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one year after surgery
Awards & highlights

Study Summary

Rheumatoid arthritis (RA) is a frequent inflammatory arthritis that can lead to severe joint deformity and often requires orthopaedic surgical interventions. Anti-Tumor Necrosis Factor α (anti-TNFα) are biological disease-modifying antirheumatic drugs (DMARDs) increasingly used in the treatment of rheumatoid arthritis. An increased risk of opportunistic infection was demonstrated in patients treated with those drugs. This observation led many national committees to recommend anti-TNFα suspension in the perioperative period to avoid a raise in the postoperative infection risk in those patients. This approach is not supported by the data available in the current literature and it exposes patients to an increased risk of inflammatory flare ups of their disease during and after anti-TNFα suspension, which can compromise their postoperative rehabilitation and their quality of life. The objective of this prospective randomized multicentric trial is to determine the effect of anti-TNFα suspension in the perioperative period on the postoperative infection risk. Overall, 660 rheumatoid arthritis patients requiring an elective foot or ankle surgery will be randomized into two groups. In the first group, anti-TNFα will be stopped 3 half-lives before the surgery while they will be continued in the second group. The postoperative infection rate will be compared between the two groups. Postoperative complication rates, flares and revision surgeries as well as the functional improvement will be compared. The study hypothesis is that there is no significant difference in the risk of postoperative infection between the two groups. Results from this study will help determine the optimal way to use anti-TNFα in the perioperative period and will therefore improve the quality of life of rheumatoid arthritis patients.

Eligible Conditions
  • Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time the drug is suspended until one year after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time the drug is suspended until one year after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical site infection
Secondary outcome measures
Change in functional level
Disease flare up
Poor wound healing
+1 more
Other outcome measures
Other adverse events

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Anti-TNFα continued perioperativelyExperimental Treatment1 Intervention
Patients randomized to Group A will continue their anti-TNFα treatment unaltered during the whole perioperative period. Surgery will be performed without consideration in regards to the timing of the treatment. The time elapsed between the last anti-TNFα administration and the surgery will nonetheless be documented.
Group II: Anti-TNF suspended perioperativelyActive Control1 Intervention
Patients randomized to Group B will have their anti-TNFα therapy interrupted before surgery. Different authors suggested that anti-TNFα therapies should be suspended between two and five half-lives prior to surgery. In the current trial, anti-TNFα will be suspended three half-lives (± seven days) prior to surgery. All other medications used in the treatment of the disease (methotrexate, hydroxychloroquine, corticosteroid, etc.) will be documented and continued in the perioperative period. Non-steroidal anti-inflammatory drugs (NSAID) will be suspended seven days prior to surgery and will be restarted postoperatively. Anti-TNFα will be restarted once wound healing is completed.

Find a Location

Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor
167 Previous Clinical Trials
106,497 Total Patients Enrolled
2 Trials studying Rheumatoid Arthritis
332 Patients Enrolled for Rheumatoid Arthritis
Mélissa Laflamme, MD, MsCPrincipal InvestigatorCentre Hôspitalier Universitaire de Québec

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~68 spots leftby Apr 2025