E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid Arthritis and Systemic Lupus Erythematosus |
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E.1.1.1 | Medical condition in easily understood language |
A serious illness that damages your joints and makes them swell, stiff and painful and an inflammatory disease of connective tissue with eg fever, weakness, fatigability, joint pains and skin lesions. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 and 8 weeks of treatment. |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4, week 8 and week 12 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |