Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis

NCT01602302 | Terminated Phase 4 DMC

• 2 other identifiers: 2011-5; V22011-005204-15
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

biological DMARDs may be stopped in Rheumatoid Arthritis (RA) patients treated with a combination of synthetic DMARD plus bDMARDs which are in persistent clinical remission. The research question of this study is, whether musculoskeletal sonography is a useful biomarker predicting a disease flare after cessation of bDMARD therapy.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; ultrasound; remission; biological DMARD

Outcome Measures

Primary Outcomes (1)

• PD-signals predict relapse at week 16

  Active inflammation at the time of bDMARD withdrawal indicated by the presence of a PD-score ≥1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 16.

  16 weeks

Secondary Outcomes (10)

• PD-signals predict relapse at week 24

  24 weeks

• PD-signals predict relapse at week 52

  52 weeks

• PD-scores at time of relapse

  24 weeks

• Increment of PD-scores precede flare

  52 weeks

• PD scores better predict a relapse than residual swollen joints

  16, 24, 52 weeks

Study Arms (1)

single arm ( bDMARD withdrawal )

EXPERIMENTAL

single arm (bDMARD withdrawal)

Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)

Interventions

bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept) DRUG

bDMARDS (etanercept, adalimumab, infliximab, certolizumab, golimumab, tocilizumab, abatacept) will be discontinued after baseline visit in all participants

Also known as: Enbrel, Humira, Remicade, Cimzia, Simponi, Roactemra, Orencia

single arm ( bDMARD withdrawal )

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient ≥18 years and \<90 years of age
• Classification of RA according to the ACR/EULAR 2010 criteria
• Persistent clinical remission as defined by the ACR/EULAR remission criteria for at least 6 months (documented at ≥2 visits)
• Written informed consent
• Current treatment with a single csDMARD or a combination of csDMARDs plus a stable dose and administration interval (for the last 6 months) of a TNF-alpha inhibitor
• No current systemic corticosteroid treatment (stopped for at least 4 weeks), no corticosteroid injection within 4 weeks
• Stable dose of NSAIDs for at least 1 week

You may not qualify if:

• Current treatment with any investigational drug
• Current administration interval of the anti-TNF-alpha agent of \>11 weeks
• Complete destruction of any joint to be investigated by sonography
• Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA- manifestation with the exception of rheumatoid nodules
• Initial arthritis manifestations before the age of 17 years
• Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography
• Current severe medical illness requiring hospitalization
• Active infection or active malignancy at screening or infection during the past 4 weeks requiring (even temporary) discontinuation of the anti-TNF-alpha agent
• Pregnancy or lactation
• Inability of the patient to follow the protocol
• Current treatment with Rituximab (MabThera®)

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Adalimumab; Infliximab; Certolizumab Pegol; golimumab; Abatacept; tocilizumab

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)

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

Study Officials

• Christian Dejaco, MD, PhD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD, Dr.

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 18, 2012
• Study Start: June 1, 2012
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

AU (1)