To evaluate the clinical course in RA after cessation of TNF blockade and to determine biomarkers of successful cessation of TNF blockade.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is:
1. The percentage of patients that sustain drug-free remission 24 months after
the cessation of TNF-antagonists
2. Predictors (e.g. clinical parameters, serological and immunological markers)
of sustained drug-free remission
Secondary outcome
1. The difference in genetic markers/ epigenetic markers (e.g. genetic
polymorphisms/ methylation status) in TNF-* genes that predict sustained
drug-free remission in the individual patient
2. Explore new markers, e.g. by micro-array analysis, distinguishing patients
with sustained drug-free remission from patients who relapse.
3. Determine the percentage of patients with subclinical synovitis as
determined by ultrasound in this group of patients in clinical remission
Background summary
The ability to predict successful cessation of TNF blockade would have
significant implications not only because anti-TNF treatment elevates the risk
for adverse events such as infections, but also for financial reasons.
Study objective
To evaluate the clinical course in RA after cessation of TNF blockade and to
determine biomarkers of successful cessation of TNF blockade.
Study design
Following a screening period of 2 weeks, patients will be enrolled into a
prospective study for a period of 24 months. At baseline they will stop using
their current TNF-blocker.
Patients will continue the use of concomitant non-steroidal anti-inflammatory
drugs (NSAIDs) and DMARDs in the dosage they used before the start of the
trial.
Clinical evaluation of joint pain and swelling will be done at baseline and
repeated after 3, 6, 9, 12, 15, 18, 21 and 24 months. Patients will be seen for
efficacy and safety assessments in accordance with standard guidelines for
clinical practice. In addition an ultrasound of both wrists, all
metocarpophalageal joints and proximal interphalageal joints will be done to
evaluate possible subclinical synovial hypertrophy.
In total there will be 10 study visits: screening, baseline, 3 months, 6
months, 9 months, 12 months, 15 months, 18 months, 21 months and 24 months.
There will be a ± 7 day deviation for all return visits. All visits will be
fixed with reference to the baseline visit. Furthermore an withdrawal will take
place if a flare occurs and this is not within 7 days of a scheduled assessment
and a safety-follow up visit will be done 3 months after withdrawal from the
study.
Study burden and risks
n.a.
Meibergdreef 9 F4-105
1105 AZ Amsterdam ZO
NL
Meibergdreef 9 F4-105
1105 AZ Amsterdam ZO
NL
Listed location countries
Age
Inclusion criteria
Men/women suffering from rheumatoid arthritis, based on the 2010 American College of Rheumatology/ European league Against Rheumatism (ACR/EULAR) classification criteria for RA will be included in this study.;Patients in ARA functional classes I, II, and III may be included.;In addition, patients must fulfill the following criteria at baseline:
1) DAS 28 * 2.6 for the duration of a minimum of 24 weeks
2) Be > 18 years of age and * 85 years.
3) Stable use of concomitant DMARDs and TNF antagonists for the duration of 24 weeks before baseline
Exclusion criteria
1) The use of oral/ intra-articular corticosteroids within 6 months prior to baseline
2) Pregnancy
3) Breastfeeding
4) Subjects who are impaired, incapacitated, or incapable of completing study
related assessments.
5) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus
erythematous).
6) Subjects with active vasculitis of a major organ system with the exception of
rheumatoid nodules.
7) Subjects with current symptoms of severe, progressive, or uncontrolled renal,
hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
cerebral disease, or other medical conditions that, in the opinion of the
investigator, might place the subject at unacceptable risk for participation in this
study.
8) Subjects who have clinically significant drug or alcohol abuse.
9) Inability to give informed consent
10) Mental condition rendering the patient unable to understand the na¬ture, scope
and possible consequences of the study and/or evidence of an uncooperative attitude.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33643.018.10 |