The Role of Conditioning for Pharmacotherapeutic Treatments in Rheumatoid Arthritis.

Recruiting

Conditions: rheumatoid arthritis & inflammatory arthritis
10003816

Registration Number: NL-OMON44827

Lead Sponsor: niversiteit Leiden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

Adult (minimum age of 18 years), recent-onset RA, fluent in Dutch, able to give informed consent, in clinical remission at month 5 after completing the protocolized pharmacological treatment.

Exclusion Criteria

- Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception.
- Concomitant treatment with another experimental drug.
- History or presence of malignancy within the last five years.
- Bone marrow hypoplasia.
- Elevated hepatic enzyme levels (ASAT, ALAT > 3 times normal value).
- Serum creatinine levels > 150 umol/l or estimated creatinine clearance of < 75%.
- Uncontrolled diabetes mellitus (according to the rheumatologist).
- Uncontrolled hypertension or moderate to severe heart failure (NYHA class III/IV).
- Alcohol or drug abuse.
- History of infected joint prosthesis within the previous 3 months.
- Serious infections, such as hepatitis, pneumonia, pyelonephrititis in the previous 3 months.
- Chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis.
- History of opportunistic infections such as herpes zoster within previous 2 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the percentage of patients who achieve a<br /><br>drug-free clinical remission (DAS < 1.6) following the tapering period, 12<br /><br>months after the start of the treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome measures include the percentage of patients achieving a<br /><br>clinical remission, clinician- and patient-assessed clinical functioning (e.g.,<br /><br>disease activity), laboratory assessments (e.g., cytokine levels), and<br /><br>self-report outcomes (e.g., side effects) following the experimental period (8<br /><br>months), the tapering period (12 months), and during the end-of-study visit (16<br /><br>months). Additionally, the possible influence of psychological and genetic<br /><br>predictors on the susceptibility to conditioning will be explored. Finally, a<br /><br>cost-effectiveness analysis will be performed to investigate the<br /><br>cost-effectiveness of the conditioning procedure compared to standard<br /><br>treatment.</p><br>