Systemic Sclerosis
Conditions
Interventions
HP3.073.433.101
The general objective of this proposal is to investigate, through a clinical trial, the immunomodulatory activity of the drug Simvastatin in the presentation of tablets used orally, and its effects on
Sponsors
Sociedade Brasileira de Reumatologia
Hospital das Cllinicas da Universidade Federal de Pernambuco
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Diagnosis of Systemic Sclerosis according to the American College of Rheumatology; minimum and maximum age between eighteen and seventy years of age; serum total cholesterol levels up to 200mg/dl; written consent to participate in the study
Exclusion criteria
Exclusion criteria: Pregnant women; intolerance or allergy to simvastatin or its derivatives; being in use or having used it for less than 30 days; diabetes mellitus; heart failure; renal failure; hypertension; myopathies; hypothyroidism; smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome 1: modified Ronan score (mRSS), it is expected to find variations in this outcome, which assesses the degree of skin thickening, in the intervention group when compared to the placebo group at the study times: D0, D60, D90 and D120;Outcome 1 Result: After evaluations at 4 times, NO changes were observed in the modified Rodnan score when correlated with cytokine dosages in both groups studied (simvastatin and placebo). ;Primary outcome 2: sHAQ (Scleroderma Health Assessment Questionnaire) this outcome assesses the degree of impact of SSc referring to complications inherent to SSc in patients' routine activities. It is expected to find variations in this outcome, which, evaluating the degree of impact, in the intervention group when compared to the placebo group at the study times: D0, D60, D90 and D120;Outcome 2 Result: After the 4-point assessments, NO changes were observed in the sHAQ score when correlated with cytokine dosages in both studied groups (simvastatin and placebo).;Primary outcome 3: the HAQ (Health Assessment Questionnaire) this outcome assesses the degree of impact of SSc on the patient's usual and routine activities. It is expected to find variations in this outcome, which assesses the degree of impact, in the intervention group when compared to the placebo group at the study times: D0, D60, D90 and D120;Outcome Result 3: After the assessments at 4 times, NO changes were observed in the HAQ score when correlated with the cytokine dosages in both studied groups (simvastatin and placebo).;Primary Outcome 4: To evaluate the cytokines and chemokines, IL4, IL6, IL8, IP10(CCL-10), IL13, IL17, IL-29 CL-2 at times D0, D60, D90 and D120, in the intervention group and in the placebo group and it is expected to find variations regarding the secretion of these cytokines in patients with SSc to observe whether or not there is immunomodulation in this serious disease;Results of primary outcome 4: When analyzing IL-6 at the time of the study, we obs | — |
Secondary
| Measure | Time frame |
|---|---|
| We didn't expect and we didn't have secondary outcomes | — |
Countries
Brazil
Contacts
Public ContactLilian Valadares
Hospital das Cllinicas da Universidade Federal de Pernambuco
Outcome results
None listed