Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 27 December 2021
• 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: 93
• Recruitment status: Completed
• 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: Eloisa Bonfa, MD, PhD
• 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

Juvenile SLE

Systemic Lupus Erythematosus (SLE)

Cutaneous Lupus

Intervention(s)

Drug: Thalidomide

Drug: Hydroxychloroquine reduced

Drug: standard dose of HCQ

Primary Outcome(s)

Serum Levels of Thalidomide [Time Frame: 12 months]

Serum Levels of Hydroxycloroquine [Time Frame: 12 months]

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

Results

• Results available: Yes
• Date Posted: 16/12/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03122431