E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sjogren's Syndrome |
Syndroom van Sjogren |
|
E.1.1.1 | Medical condition in easily understood language |
Sjogren's Syndrome |
Syndroom van Sjogren |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040766 |
E.1.2 | Term | Sjogren's disease |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10040767 |
E.1.2 | Term | Sjogren's syndrome |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042846 |
E.1.2 | Term | Syndrome Sjogren's |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040765 |
E.1.2 | Term | Sjogren's |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 |
Reduction in disease activity, measured by ESSDAI (EULAR Sjogren's syndrome disease activity index) |
Afname van ziekteactiviteit, gemeten door middel van de ESSDAI (EULAR Sjogren's syndrome disease activity index) |
|
E.2.2 | Secondary objectives of the trial |
Improvement of dryness measured by stimulated whole saliva output |
Verbetering van droogheidssymptomen, gemeten door bepalen van gestimuleerde speekselproductie |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) women, age 18-75 years
2) pSS diagnosed according to the American-European Consensus Criteria, revised in 2002
3) lymphocyte focus score (local lymphocytic infiltrates) ≥1 in sublablial salivary gland specimen.
4) ESSDAI ≥ 5
5) presence of autoantibodies directed to pSS-related SSA and/or SSB nuclear antigens
6) use of a reliable method of contraception
7) signed written informed consent
|
1) vrouwelijk geslacht, 18-75 jaar
2) gediagnosticeerd met pSS volgens de American-European Consensus Critera, herzien in 2002
3) Lymfocyt Focus Score (lokale infiltraties van lymfocyten) ≥1 in sublabiaal speekselklierbiopt
4) ESSDAI ≥ 5
5) aanwezigheid van auto-antilichamen gericht tegen pSS-gerelateerde SSA en/of SSB nucleaire antigenen
6) gebruik van betrouwbare vorm van anticonceptie
7) ondertekende informed consent
|
|
E.4 | Principal exclusion criteria |
1) Pregnancy or the wish to conceive during the study or within 2 years after the study
2) Breastfeeding
3) Therapy-resistent hypertension
4) Maculopathy or retinitis pigmentosa
5) Secondary Sjogren’s Syndrome
6) Hepatic or renal impairment
7) Severe infection (including hepatitis B,C or HIV)
8) Malignancy other than mucosa-associated lymphoid tissue lymphoma (MALT lymphoma)
9) Significant cytopenia
10) Concomitant cardiac- and inflammatory bowel disease
11) Sarcoidosis
12) Usage of LEF of HCQ <6 months prior to inclusion
13) Usage of immunosuppressive drugs, with the exception of a stable dose of non- steroidal inflammatory drugs and a stable, low dose (≤7.5 mg) of oral corticosteroids
14) Inadequate mastery of the Dutch language
|
1) Zwangerschap of de wens tot conceptie tijdens de studie of binnen twee jaar na afronding van de studie
2) Borstvoeding
3) Therapie-resistente hypertensie
4) Maculopathie of retinitis pigmentosa
5) Secundair Syndroom van Sjogren
6) Stoornissen in nier- of leverfuncties
7) Ernstige infectie (incl hepatitis B en C, HIV)
8) Maligniteit, anders dan mucosa-associated lymphoid tissue MALT) lymphoma
9) Significante cytopenie
10) Begeleidende cardiale- en inflammatoire darm ziekten
11) Sarcoidose
12) Gebruik van LEF of HCQ < 6 maanden voorafgaand aan inclusie
13) Gebruik van immunosuppressieve medicatie, muv een stabiele dosis NSDAID en een stabiele, lage (≤7.5 mg) orale corticosteroiden
14) Onvoldoende beheersing van de Nederlandse taal |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of disease activity measured by ESSDAI |
Vermindering van ziekte-activiteit gemeten dmv ESSDAI |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 24 weeks of treatment with either LEF and HCQ, or placebo-LEF and placebo-HCQ |
Na 24 weken behandeling met ofwel LEF en HCQ, ofwel placebo-LEF en placebo-HCQ |
|
E.5.2 | Secondary end point(s) |
Dryness measured by stimulated whole saliva |
Droogheid gemeten door gestimuleerde speekselproductie |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 24 weeks of treatment with either LEF and HCQ, or placebo |
Na 24 weken behandeling met ofwel LEF en HCQ, ofwel placebo |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immunologic response |
Immunologische respons |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
Last visit of the last patient included |
Laatste bezoek van de laatst geincludeerde patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |