Anti-TNFα Use During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis

NCT02242474 | Unknown Phase 4 DMC

• 1 other identifier: 1-levallee
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Surgical Wound Infection; Surgical Site Infection; Antirheumatic Agents; Perioperative Care; Anti-TNF; Anti-TNF-alpha

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

  Surgical site infection will be determined according to the definition of the Center for Disease Control (CDC).

  Within one year after surgery

Secondary Outcomes (4)

• Disease flare up

  From the time the drug is suspended until one year after surgery

• Change in functional level

  Until one year after surgery

• Poor wound healing

  Within one year of surgery or until wound is completely healed

• Reoperation rate

  Within one year of surgery

Other Outcomes (1)

• Other adverse events

  Within one year of surgery

Study Arms (2)

Anti-TNF suspended perioperatively

ACTIVE COMPARATOR

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.

Drug: Anti-TNF suspended perioperatively

Anti-TNFα continued perioperatively

EXPERIMENTAL

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.

Drug: Anti-TNFα continued perioperatively

Interventions

Anti-TNF suspended perioperatively DRUG

Also known as: Infliximab, Remicade, Etanercept, Enbrel, Adalimumab, Humira, Certolizumab, Cimzia, Golimumab, Simponi

Anti-TNF suspended perioperatively

Anti-TNFα continued perioperatively DRUG

Also known as: Infliximab, Remicade, Etanercept, Enbrel, Adalimumab, Humira, Certolizumab, Cimzia, Golimumab, Simponi

Anti-TNFα continued perioperatively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female 18 years of age or older
• Rheumatoid arthritis diagnostic according to the American College Rheumatology (ACR) 1987 criteria \[38\]
• Patient treated with anti-TNFα for at least six months
• Elective unilateral surgery of the foot and ankle

You may not qualify if:

• Patient unable to give informed consent
• Surgery on an infected site
• Severe distal peripheral vascular disease (no distal pulse)
• Medical condition contraindicating surgery
• Patient treated with biologic DMARD other than anti-TNFα
• Circumstances preventing an adequate postoperative follow-up
• Revision surgery

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead

Study Sites (1)

Centre Hospitalier Universitaire de Québec

Québec, Quebec, G1V 2L9, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Surgical Wound Infection

Interventions

Infliximab; Etanercept; Adalimumab; Certolizumab Pegol; golimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments

Study Officials

• Mélissa Laflamme, MD, MsC

  Centre Hôspitalier Universitaire de Québec

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Laflamme, MD, MSc

CONTACT

418-525-4444

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCSC, Orthopedic surgeon

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: July 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CA (1)