Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)
- Conditions
- Rheumatoid Arthritis and Systemic Lupus ErythematosusTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-005418-45-SE
- Lead Sponsor
- Christine Bengtsson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Male or female, 18-65 years of age, who has given written consent for his/her par-ticipation to the study
ACR criteria for RA and SLE
< 10mg Prednisolon daily doses
Low-medium disease activity DAS28 <4.6-RA, SLEDAI-2k <6 SLE (Arthritis accepted)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
•Antimalarial medication less than5 ½-t= 250 days before study inclusion visit
•High disease activity, where cortison ad-justment is predictable
•Pleuritis or Pericarditis – SLE
•Impaired visus and/or colour vision
•Hypertension >160/95
•Diabetes
Short life expectancy due to other comor-bidity
Documented allergy or intolerance to study drug
Severe psychiatric condition or other reason that jeopardize compliance with fol-low up.
On fertile females, pregnancy assessed by anamnesis and pregnancy test
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method