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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03122431
Date of registration: 17/04/2017
Prospective Registration: Yes
Primary sponsor: University of Sao Paulo General Hospital
Public title: Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases
Scientific title: Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects
Date of first enrolment: June 5, 2017
Target sample size: 296
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03122431
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Brazil
Contacts
Name:     Sandra G Pasoto, M.D., PhD.
Address: 
Telephone: 30617490
Email: sandra.pasoto@hc.fm.usp.br
Affiliation: 
Name:     Eloisa Bonfa, MD, PhD
Address: 
Telephone: 55 11 30617490
Email: eloisa.bonfa@hc.fm.usp.br
Affiliation: 
Name:     Eloisa Bonfa, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Sao Paulo
Key inclusion & exclusion criteria

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



Age minimum: 5 Years
Age maximum: 64 Years
Gender: All
Health Condition(s) or Problem(s) studied
Cutaneous Lupus
Juvenile SLE
Systemic Lupus Erythematosus (SLE)
Intervention(s)
Drug: Hydroxychloroquine high
Drug: Hydroxychloroquine reduced
Drug: Thalidomide
Primary Outcome(s)
Serum levels of hydroxycloroquine - HCQ high [Time Frame: 3 months]
Serum levels of hydroxycloroquine - HCQ reduced [Time Frame: 6 months, 12 months and 24 months]
Serum levels of thalidomide [Time Frame: 30 days, 3 months, 6 months and 12 months]
Secondary Outcome(s)
Secondary ID(s)
HPLC-Rheumatic diseases
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Fundação de Amparo à Pesquisa do Estado de São Paulo
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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