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NCT Number: NCT07138898

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

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Key information

Conditions

Rheumatic Disease Ankylosis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Arteritis Arthritis Arthritis, Juvenile Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Autoimmune Diseases of the Nervous System Axial Spondyloarthritis Bone Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Connective Tissue Diseases Dermatomyositis Giant Cell Arteritis Granulomatosis with Polyangiitis Immune System Diseases Joint Diseases Lung Diseases Lung Diseases, Interstitial Lupus Erythematosus, Systemic Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyalgia Rheumatica Polymyositis Psoriasis Respiratory Tract Diseases Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin Diseases, Vascular Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Systemic Vasculitis Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years and older at the time of informed consent;
  • Diagnosis of rheumatic disease: rheumatoid arthritis (RA), psoriatic arthritis (PA) , ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), spondyloarthritis, polymyalgia rheumatica, giant cell arteritis, vasculitis, granulomatosis with polyangiitis, dermatomyositis, polymyositis, and inflammatory bowel disease-associated arthritis;
  • On active immunosuppression for at least 3 months prior to scheduled surgery;
  • Scheduled for elective total shoulder arthroplasty;
  • Able and willing to provide written informed consent prior to any study specific procedures.

Exclusion criteria

  • Patients with active infections or malignancies;
  • Patients undergoing shoulder arthroplasty for fracture or tumor;
  • Pregnancy or breastfeeding;
  • Unable to provide informed consent;
  • Patients with severe SLE with marked activity - as they should be offered enrollment in the observational arm. All such patients should remain on treatment to avoid worsening of disease activity;
  • Unable or without capacity to provide written informed consent prior to any study specific procedures.

Treatment and study plan

methotrexate

Drug

Continue throughout perioperative period

Sulfasalazine

Drug

Continue throughout perioperative period

Hydroxychloroquine

Drug

Continue throughout perioperative period

Other names: Plaquenil

leflunomide

Drug

Continue throughout perioperative period

Other names: Arava

azathioprine

Drug

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

Other names: Imuran

Mycophenolate

Drug

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

Other names: Cellcept

cyclosporine

Drug

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

Tacrolimus

Drug

Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery

etanercept

Drug

Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose

Other names: Enbrel

Adalimumab

Drug

Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose

Other names: Humira

Golimumab

Drug

Control group: Schedule surgery 5 weeks after last administered 4-week subcutaneous dose or 9 weeks after last administered 8-week intravenous dose.

Intervention group: Schedule surgery 2 weeks after last administered 4-week subcutaneous dose or 4 weeks after last administered 8-week intravenous dose.

Other names: Simponi

Certolizumab

Drug

Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.

Other names: Cimzia

Infliximab

Drug

Control group: Schedule surgery 9 weeks after last administered intravenous dose.

Intervention group: Schedule surgery 4 weeks after last administered dose.

Other names: Remicaide

Rituximab

Biological

Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.

Other names: Rituxan

Belimumab

Biological

Control group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose.

Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.

Other names: Benlysta

Tocilizumab

Biological

Control group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose.

Intervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.

Other names: Actemra

Anakinra

Biological

Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.

Other names: Kineret

canakinumab

Biological

Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.

Other names: Ilaris

Abatacept

Biological

Control group: Schedule surgery 2 weeks after last administered weekly subcutaneous dose or 5 weeks after last administered monthly intravenous dose.

Intervention group: Schedule surgery 1 week after last administered weekly subcutaneous dose or 2 weeks after last administered monthly intravenous dose.

Other names: Orencia

Secukinumab

Biological

Control group: Schedule surgery 5 weeks after last administered subcutaneous dose.

Intervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.

Other names: Cosentyx

Ixekizumab

Biological

Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.

Other names: Taltz

Bimekizumab

Biological

Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose

Other names: Bimzelx

Ustekinumab

Biological

Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.

Other names: Stelara

Guselkumab

Biological

Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4.5 weeks after last administered 8-week dose.

Other names: Tremfya

risankizumab

Biological

Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6-7 weeks after last administered 12-week dose.

Other names: Skyrizi

tofacitinib

Drug

Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.

Other names: Xeljanz

Upadacitinib

Drug

Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery

Other names: Rinvoq

Primary outcomes

  1. Incidence of wound complications

    Time frame: 90-day post operation

  2. Incidence of superficial surgical site infections

    Time frame: 90-day post operation

  3. Incidence of deep surgical site infections

    Time frame: 90-day post operation

  4. Incidence of return trips to the operating room

    Time frame: 90-day post operation

  5. Incidence of rheumatologic disease flares

    Time frame: 90-day post operation

Secondary outcomes

  1. Length of hospital stay

    Time frame: From admission to discharge (on average 2 days)

  2. Postoperative pain score as assessed by the VAS for Pain

    Time frame: Week 2

    Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

  3. Postoperative pain score as assessed by the VAS for Pain

    Time frame: Week 6

    Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

  4. Postoperative pain score as assessed by the VAS for Pain

    Time frame: Month 3

    Visual Analogue Scale (VAS) for Pain is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.

  5. Change in Range of motion (ROM) - active forward elevation (AFE)

    Time frame: Week 2, Month 3

    The normal range for AFE is between 170 and 180 degrees. A decrease suggests reduced range of motion.

  6. Change in Range of motion (ROM) - external rotation (ER)

    Time frame: Week 2, Month 3

    Normal ER ROM can range from 70 to 90 degrees. A decrease suggests reduced range of motion.

  7. Change in Range of motion (ROM) - internal rotation (IR)

    Time frame: Week 2, Month 3

    The normal IR ROM is 70 to 90 degrees. A decrease suggests reduced range of motion.

  8. Change in PROMIS - Physical Function (PF) - Short Form 10a

    Time frame: Week 2, Month 3

    The PROMIS PF-10a asks respondents to rate their ability to perform 10 physical activities. The responses are summed to create a raw score, which ranges from 10 (representing the lowest level of physical function) to 50 (representing the highest level of physical function).

  9. Change in PROMIS - Pain Interference - Short Form 6a

    Time frame: Week 2, Month 3

    The questionnaire consists of 6 items assessing pain interference. Participants are asked to rate each item from 1 (not at all) to 5 (very much). The PROMIS Pain Interference - Short Form 6a has a possible raw score range of 6 to 30, where higher scores indicate greater pain interference. This raw score is then converted to a T-score, which has a mean of 50 and a standard deviation of 10 in a reference population.

  10. Change in American Shoulder and Elbow Surgeons (ASES) score

    Time frame: Week 2, Month 3

    The ASES questionnaire is a patient-reported outcome measure used to assess shoulder function and pain. It includes a pain scale (using a visual analog scale) and a functional subscale assessing activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

  11. Change in Disabilities of the Arm, Shoulder and Hand (DASH) score

    Time frame: Week 2, Month 3

    The DASH is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Scores range from 0 to 100, with 0 indicating no disability and 100 indicating the most severe disability. A higher DASH score reflects greater disability and severity of symptoms.

  12. Proportion of participants who used rescue medications or corticosteroid bursts

    Time frame: Month 3

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Chalothron

CONTACT

[email protected]

646-501-7384

Vinay Bijoor

CONTACT

[email protected]

914-610-6112

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 24, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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