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

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ClinicalTrials.gov Identifier: NCT02242474
Recruitment Status : Recruiting
First Posted : September 17, 2014
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mélissa Laflamme, CHU de Quebec-Universite Laval

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Anti-TNF suspended perioperatively Drug: Anti-TNFα continued perioperatively Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Multicentric Trial on Anti-TNFα Treatment and Infection Risk in the Perioperative Period During Elective Foot and Ankle Surgery in Patients With Rheumatoid Arthritis.
Study Start Date : July 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Anti-TNF suspended perioperatively
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
Other Names:
  • Infliximab
  • Remicade
  • Etanercept
  • Enbrel
  • Adalimumab
  • Humira
  • Certolizumab
  • Cimzia
  • Golimumab
  • Simponi

Experimental: Anti-TNFα continued perioperatively
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
Other Names:
  • Infliximab
  • Remicade
  • Etanercept
  • Enbrel
  • Adalimumab
  • Humira
  • Certolizumab
  • Cimzia
  • Golimumab
  • Simponi




Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: Within one year after surgery ]
    Surgical site infection will be determined according to the definition of the Center for Disease Control (CDC).


Secondary Outcome Measures :
  1. Disease flare up [ Time Frame: From the time the drug is suspended until one year after surgery ]

    There is currently no widely accepted definition of RA disease flare up. In this study, patients satisfying one of the two following criteria will be considered as having a disease flare up:

    I. Modification of the medication made necessary by an increase in the disease symptoms.

    II. Increase in disease activity according to the Clinical Disease Activity Index (CDAI):

    1. Increase from a remission or a low disease activity level at baseline to a moderate or high activity level.

      or

    2. Increase from a moderate disease activity level at baseline to a high activity level.

      or

    3. An increase of 12 points or more on the CDAI in patients having a high disease activity level at baseline.

  2. Change in functional level [ Time Frame: Until one year after surgery ]
    The functional level of each patient is going to be assessed using the Health Assessment Questionnaire (HAQ) before and after the surgery in accordance with the follow-up schedule presented in the protocol.

  3. Poor wound healing [ Time Frame: Within one year of surgery or until wound is completely healed ]
    Complications associated with poor wound healing such as delayed wound healing and dehiscence will be noted. Delayed wound healing will be defined as a wound that isn't completely healed 14 days after surgery. Dehiscence will be defined as a wound that requires secondary closure or a wound that heals by secondary intention.

  4. Reoperation rate [ Time Frame: Within one year of surgery ]
    All reoperations made necessary following postoperative complications (ex : infection, implant retrieval, debridement) will be documented. More than one reoperation can be performed for the same patient. The reoperation rate expressed as a percentage will be compared between the two groups.


Other Outcome Measures:
  1. Other adverse events [ Time Frame: Within one year of surgery ]
    All other significant adverse events will be documented. For example, systemic infection, septic choc, implant loosening and arthrodesis nonunion are going to be noted. Nonunion is going to be defined as the persistence of a joint space on more than 50% of the articular surface visible on CT-Scan six months after surgery associated with pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02242474


Contacts
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Contact: Melissa Laflamme, MD, MSc 418-525-4444 ext 46618

Locations
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Canada, Quebec
Centre Hospitalier Universitaire de Québec Recruiting
Québec, Quebec, Canada, G1V 2L9
Contact: Melissa Laflamme, MD, MSc    418-525-4444 ext 46618      
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Investigators
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Principal Investigator: Mélissa Laflamme, MD, MsC Centre Hôspitalier Universitaire de Québec

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Responsible Party: Mélissa Laflamme, MD, MSc, FRCSC, Orthopedic surgeon, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02242474     History of Changes
Other Study ID Numbers: 1-levallee
First Posted: September 17, 2014    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Keywords provided by Mélissa Laflamme, CHU de Quebec-Universite Laval:
Rheumatoid arthritis
Surgical Wound Infection
Surgical Site Infection
Antirheumatic Agents
Perioperative Care
Anti-TNF
Anti-TNF-alpha

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Infliximab
Certolizumab Pegol
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors