Certolizumab and Lower Extremity Lymph Flow in Rheumatoid Arthritis (RA)

NCT01098201 | Completed

• 1 other identifier: RSRB - 27553
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label pilot study will select subjects who are inadequate responders to methotrexate. These subjects will receive certolizumab subcutaneously on a monthly basis for six months. The study is attempting to determine the following:

1. 1.Is lymphatic flow altered in the extremities of RA patients with an inflamed knee?
2. 2.Is resolution of synovitis associated with a restoration of lymphatic flow and lymph node volume following therapy with certolizumab?
3. 3.Can Doppler ultrasound be used to detect and follow alterations of lymph node size?

Conditions

Rheumatoid Arthritis

Keywords

Certolizumab; TNF; RA; Cizmia

Outcome Measures

Primary Outcomes (6)

• Initial lymphatic flow in inflamed knee

  To examine the lymph flow in the knee joint of RA patients before therapy with certolizumab using technetium sulfur colloid scans, MRI and Doppler ultrasound.

  Week 0 (initial medication dose)

• Initial synovitis and its association with lymph flow and node volume

  To examine lymph flow and lymph node volume before therapy with certolizumab. Flow volume will be assessed using technetium sulfur colloid scans while lymph node volume will be assessed using MRI.

  Week 0 (initial medication dose)

• Initial Doppler ultrasound assessment of lymph node size

  To assess lymph node volume before therapy with certolizumab.

  Week 0 (initial medication dose)

• Post medication lymphatic flow in inflamed knee

  To examine lymph flow in the knee joint of RA patients after therapy with certolizumab using technetium sulfur colloid scans, MRI and Doppler ultrasound

  Wk 18

• Post medication synovitis and its association with lymph flow and node volume

  To examine lymph flow and lymph node volume after therapy with certolizumab. Flow volume will be assesses using tecnetium sulfur colloid scan while lymph node volume will be assessed using MRI.

  Wk 18

• Post medication Doppler ultrasound assessment of lymph node size

  To assess lymph node volume after therapy with certolizumab.

  Wk 18

Interventions

Certolizumab DRUG

Subcutaneous administration on a monthly basis for six months

Also known as: Cizmia

Eligibility Criteria

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

Study Population

Male and female RA sufferers not less than 18 yrs of age who are currently experiencing knee synovitis. Racial and ethnic origin of subjects will be monitored to reflect the diversity of our community.

You may qualify if:

• Inflammatory arthritis. Patients with RA according to the American College of Rheumatology criteria.
• Inadequate response to treatment following 3 months of methotrexate (15-20 mg per week). Inadequate response will be defined as the presence of knee inflammation and at least 2 active joints. If the knee has an effusion, fluid must be obtained to exclude infection or crystalline disease.
• Knee inflammation in one knee determined on physical exam and confirmed by Doppler ultrasound. We will include patients with bilateral knee inflammation only if one knee is more inflamed than the contralateral knee. The comparative level of inflammation will be determined by clinical examination and Doppler US.
• Patients must be willing to undergo a sulfur colloid technetium scan, knee ultrasound and MRI of the knee.

You may not qualify if:

• Contra-indication to anti-TNF agent.
• History of recurrent infections.
• Prosthetic knee joint
• Recent surgery or trauma to a knee joint
• Lymphedema
• Lymphoproliferative disorder
• Claustrophobia such that they cannot undergo an MRI of the knee
• GFR\<60 cc/min
• Morbid obesity
• Foot disease: active ankle or forefoot synovitis, recent trauma, cellulitis or edema.
• Peripheral vascular disease
• Diabetes
• Active skin inflammation in the lower extremities
• Solid Malignancy

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Rahimi H, Bell R, Bouta EM, Wood RW, Xing L, Ritchlin CT, Schwarz EM. Lymphatic imaging to assess rheumatoid flare: mechanistic insights and biomarker potential. Arthritis Res Ther. 2016 Sep 1;18:194. doi: 10.1186/s13075-016-1092-0.

  PMID: 27586634 DERIVED

• Li J, Zhou Q, Wood RW, Kuzin I, Bottaro A, Ritchlin CT, Xing L, Schwarz EM. CD23(+)/CD21(hi) B-cell translocation and ipsilateral lymph node collapse is associated with asymmetric arthritic flare in TNF-Tg mice. Arthritis Res Ther. 2011 Aug 31;13(4):R138. doi: 10.1186/ar3452.

  PMID: 21884592 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Christopher Ritchlin, MD / MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H.; Professor of Medicine Allergy, Immunology & Rheumatology Division

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 2, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 21, 2015

Record last verified: 2015-09

Locations

US (1)