Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases (NCT03122431) | Clinical Trial Compass
CompletedPhase 4
Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases
Brazil93 participantsStarted 2017-06-05
Plain-language summary
No drug treatment is completely free of risk and lack of response, adverse events and poor adherence may affect its effectiveness. Within this context, this project aims to evaluate the importance of monitoring blood levels and salivary drug used in rheumatic autoimmune diseases in the monitoring of adherence to therapy. In addition, this project intends to use the monitoring of drug levels, based on pharmacokinetic studies and pharmacokinetics/pharmacodynamics modeling, to broaden the understanding of the possible cellular, tissue and immunological mechanisms involved in efficacy and adverse effects of these drugs with the prospect of reducing the damage and maintain therapeutic efficacy. The high-performance liquid chromatography (HPLC) coupled to mass spectrometry, which will be used to evaluate hydroxychloroquine, thalidomide, glucocorticoids, is considered the gold standard technology to qualitative and quantitative analysis of drugs in blood and its comparison with the dosage in the saliva is an improvement in simplification of the process. For biological agents the focus will be on the understanding the loss of efficacy and the possible role of anti-TNF antibodies using ELISA capture methodology.This project will be divided into four sections with their respective sub-projects according to the medications that will be studied: hydroxychloroquine, thalidomide, biologic agents and glucocorticoids.
Who can participate
Age range
5 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Thalidomide subproject:
Inclusion Criteria:
* SLE diagnosis according to 1997 ACR criteria
* Active and refractory cutaneous lupus lesions
* Male gender (using contraceptive barrier method) or confirmed infertility for female gender
* Normal electroneuromyography at study entry
Exclusion Criteria:
* Alcoholism
* History of peripheral neuropathy
* Previous history of thrombophilia or positive antiphospholipid antibodies
* Renal and/or central nervous system and/or hematological activity
HCQ reduced subproject:
Inclusion Criteria:
* SLE diagnosis according to 1997 ACR criteria
* Use of hydroxychloroquine (5 to 6.5mg/kg/day) for ≥5 years
* SLEDAI-2K \<4
Exclusion Criteria:
* Alcoholism
* Renal dialysis
* Concomitant infectious process
* Acute and chronic liver diseases
* Concomitant use of some drugs that interact with HCQ (cimetidine, antacids, digoxin, aminoglycosides, penicillamine, neostigmine, pyridostigmine)
* Signs of Retinopathy
HCQ high subproject:
Inclusion Criteria:
* SLE diagnosis according to 1997 ACR criteria
* No use of hydroxychloroquine for ≥ 6 months
* LES/LESJ in activity (SLEDAI≥6)
Exclusion Criteria:
* Alcoholism
* Renal dialysis
* Concomitant infectious process
* Acute and chronic liver diseases
* Concomitant use of some drugs that interact with HCQ (cimetidine, antacids, digoxin, aminoglycosides, penicillamine, neostigmine, pyridostigmine)
* Signs of Retinopathy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.