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)

Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005418-45-SE

Enrollment

Unknown

Registered

2015-03-18

Start date

2015-05-04

Completion date

Unknown

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis and Systemic Lupus Erythematosus

Interventions

Trade Name: Plaquenil Pharmaceutical Form: Film-coated tablet INN or Proposed INN: HYDROXYCHLOROQUINE CAS Number: 118-42-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

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 • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the of HCQ treatment effects on traditional cardiovascular risk factor profile: blood lipid profile, B-glucose, blood pressure after 4 and 8 weeks in patients with RA and SLE.;Secondary Objective: To study the effect on vascular function, measured with pulse wave velocity (PWV) and inflammatory markers including cytokines, Calprotectin and Hyaluronan (HA). To study the patient´s compliance to drug pre-scription and the occurring adverse events. ;Primary end point(s): The primary endpoint is to evaluate the effect of treatment on the blood lipids; Total Choles-terol (TC), Triglycerides (TG), Low density lipoprotein (LDL), High density lipoprotein (HDL) and apolipoproteins in patients with RA and SLE.;Timepoint(s) of evaluation of this end point: 4 and 8 weeks of treatment.	—

Measure

Time frame

Main Objective: To investigate the of HCQ treatment effects on traditional cardiovascular risk factor profile: blood lipid profile, B-glucose, blood pressure after 4 and 8 weeks in patients with RA and SLE.;Secondary Objective: To study the effect on vascular function, measured with pulse wave velocity (PWV) and inflammatory markers including cytokines, Calprotectin and Hyaluronan (HA). To study the patient´s compliance to drug pre-scription and the occurring adverse events. ;Primary end point(s): The primary endpoint is to evaluate the effect of treatment on the blood lipids; Total Choles-terol (TC), Triglycerides (TG), Low density lipoprotein (LDL), High density lipoprotein (HDL) and apolipoproteins in patients with RA and SLE.;Timepoint(s) of evaluation of this end point: 4 and 8 weeks of treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): Pulse wave velocity analyses after HCQ-medication Blood-glucose- and HbA1c levels after HCQ-medication Calprotectin levels in serum after HCQ-medication Hyaluronan size – and concentration in serum after HCQ-medication Compliance to treatment; Adverse events, Compliance to drug prescription ;Timepoint(s) of evaluation of this end point: Week 4, week 8 and week 12	—

Countries

Sweden

Contacts

Public ContactChristine Bengtsson

Östersund hospital

christine.bengtsson@regionjh.se+46703805636

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 5, 2026