hidradenitis suppurativa, acne inversa
Conditions
Interventions
The first group will receive current standard treatment or so called “gold standard” therapy in HS which is oral antibiotics by means of clarithromycin SR 1 gr a day orally and a placebo s.c. injectio
Sponsors
Erasmus medical center Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: Male/female patients older than 18 years of age with active moderate to severe hidradenitis suppurativa (Hurley stage 2 or Hurley stage 3).
Exclusion criteria
Exclusion criteria: 1. Subject has been treated with systemic corticosteroids (oral or parenteral) less than 4 weeks prior to baseline. Inhaled corticosteroids for stable medical conditions are allowed; 2. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, recent cerebrovascular accidents, and any other condition, which in the opinion of the investigator, would put the subject at risk by participation in the study; 3. Subject has a history of clinically significant hematologic (e.g., severe anaemia, leukopenia, thrombocytopenia), renal, or liver disease (e.g., fibrosis, cirrhosis, hepatitis B or C), or NYHA class 3 or 4 congestive heart failure; 4. Subject has history of neurologic symptoms suggestive of CNS demyelinating disease and/or diagnosis of CNS demyelinating disease; 5. Subject has history of any cancer or lymphoproliferative disease; 6. Subject has a history of listeriosis, histoplasmosis, untreated or inadequately treated TB, persistent chronic infections, other than HS, or recent active infections requiring hospitalization or treatment with intravenous (IV) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the 1st adalimumab dose; 7. Subject is known to have immune deficiency, history of HIV, or is immune compromised; 8. Female subject who is pregnant or breast-feeding or has positive serum pregnancy test at screening or considering becoming pregnant during the study or within 150 days after the last dose of Adalimumab; 9. Subject has a history of clinically significant drug or alcohol usage in the last year; 10. Known positive Hepatitis B or C serology indicative of previous or current infection; 11. Screening clinical laboratory analyses show any of the following abnormal hepatic laboratory results: Aspartate transaminase (AST) or alanine transaminase (ALT) > 2x the upper limit of normal (ULN). Serum total bilirubin more than 1.5 mg/dL ( more than 26 micromol/L); 12. Subjects with known hypersensitivity to the constituents of study drugs (adalimumab, clarithromycin); 13. Subject who are previously treated with anti TNF-alpha.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure for the disease activity will be the modified Sartorius HS score. | — |
Secondary
| Measure | Time frame |
|---|---|
| DLQI quality of life form, Skindex-29 and a VAS pain score and a VAS patient disease global assessment score. | — |
Contacts
Public ContactH.H. Zee, van der
Erasmus Medical Center Department of Immunology/ Dermatology
Outcome results
None listed