EUCTR2014-005418-45-SE
Active, not recruiting
Phase 1
Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE
Christine Bengtsson0 sitesMarch 18, 2015
ConditionsRheumatoid Arthritis and Systemic Lupus ErythematosusTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsPlaquenil
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis and Systemic Lupus Erythematosus
- Sponsor
- Christine Bengtsson
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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