Trial Outcomes & Findings for Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases (NCT NCT03122431)
NCT ID: NCT03122431
Last Updated: 2021-12-16
Results Overview
Serum levels of thalidomide by liquid chromatography and tandem mass spectrometry (HPLC-MS/MS)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
93 participants
Primary outcome timeframe
12 months
Results posted on
2021-12-16
Participant Flow
Participant milestones
| Measure |
Inactive SLE With Standard Dose of HCQ
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed full 2016-AAO dose of HCQ (4-5.5 mg/kg/day, real body weight).
|
Inactive SLE With Reduced Dose of HCQ
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight)
|
SLE/Cutaneous Lupus With Thalidomide
Adult patients with CLE (biopsy proven)/SLE (American College of Rheumatology classification criteria, 1997) treated with thalidomide.
Inclusion criteria:
1. absence of pregnancy potential for females;
2. agreement of male patients to use condoms throughout the treatment period with thalidomide and up to 30 days after its ending, even though they had already undergone vasectomy;
3. active skin lesions;
4. no response to previous use of HCQ, prednisone 20 mg/day, and immunosuppressants/dapsone or indication of thalidomide according to the attending physician; 5) agreement of recruited patients to participate in the study according to signed informed consent form, and agreement to thalidomide use according to signed responsibility term at starting treatment and at each renewal of the prescription; 6) a normal NCS;
7\) normal serum vitamin B12 levels; 8) negative tests for hepatitis B/C and HIV; 9) negative antiphospholipid antibodies.
Exclusion criteria:
1. other associated autoimmune diseases, such as Sjogren's syndrome;
2. previous or current alcoholism;
3. diabetes mellitus;
4. history of PN;
5. previous use of thalidomide;
6. previous or current use of leflunomide, TNF-alpha inhibitors, chemotherapy and other neurotoxic drugs;
7. history of cancer or thrombosis;
8. current renal or nervous system lupus activities, autoimmune haemolytic anaemia and/or thrombocytopenia \<50,000/mm3;
9. inability to understand the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
32
|
20
|
|
Overall Study
COMPLETED
|
41
|
32
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baseline hydroxychloroquine levels in this arm were not measured.
Baseline characteristics by cohort
| Measure |
Inactive SLE With Standard Dose of HCQ
n=41 Participants
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed full 2016-AAO dose of HCQ (4-5.5 mg/kg/day, real body weight).
|
Inactive SLE With Reduced Dose of HCQ
n=32 Participants
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight).
|
SLE/Cutaneous Lupus With Thalidomide
n=20 Participants
This subproject includes only one arm of lupus patients with active and refractory cutaneous disease and eligible for Thalidomide 100mg/day for 12 months.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 10.5 • n=41 Participants
|
37 years
STANDARD_DEVIATION 6.9 • n=32 Participants
|
44.8 years
STANDARD_DEVIATION 7.6 • n=20 Participants
|
37 years
STANDARD_DEVIATION 8.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=41 Participants
|
29 Participants
n=32 Participants
|
17 Participants
n=20 Participants
|
85 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=41 Participants
|
3 Participants
n=32 Participants
|
3 Participants
n=20 Participants
|
8 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=41 Participants
|
6 Participants
n=32 Participants
|
9 Participants
n=20 Participants
|
28 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
28 Participants
n=41 Participants
|
26 Participants
n=32 Participants
|
11 Participants
n=20 Participants
|
65 Participants
n=93 Participants
|
|
Drug blood levels
|
1343.5 ng/mL
STANDARD_DEVIATION 521.5 • n=41 Participants • Baseline hydroxychloroquine levels in this arm were not measured.
|
1404.9 ng/mL
STANDARD_DEVIATION 492.0 • n=32 Participants • Baseline hydroxychloroquine levels in this arm were not measured.
|
—
|
1374.2 ng/mL
STANDARD_DEVIATION 506.8 • n=73 Participants • Baseline hydroxychloroquine levels in this arm were not measured.
|
PRIMARY outcome
Timeframe: 12 monthsSerum levels of thalidomide by liquid chromatography and tandem mass spectrometry (HPLC-MS/MS)
Outcome measures
| Measure |
SLE/Cutaneous Lupus With Thalidomide
n=20 Participants
Adult patients with CLE (biopsy proven)/SLE (American College of Rheumatology classification criteria, 1997) treated with thalidomide.
|
Inactive SLE With Reduced Dose of HCQ
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight)
|
|---|---|---|
|
Serum Levels of Thalidomide
|
415.1 ng/mL
Standard Deviation 326.0
|
—
|
PRIMARY outcome
Timeframe: 12 monthsSerum levels of hydroxycloroquine by LCMS
Outcome measures
| Measure |
SLE/Cutaneous Lupus With Thalidomide
n=41 Participants
Adult patients with CLE (biopsy proven)/SLE (American College of Rheumatology classification criteria, 1997) treated with thalidomide.
|
Inactive SLE With Reduced Dose of HCQ
n=32 Participants
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight)
|
|---|---|---|
|
Serum Levels of Hydroxycloroquine
|
991.6 ng/mL
Standard Deviation 576.3
|
569.0 ng/mL
Standard Deviation 533.4
|
Adverse Events
SLE/Cutaneous Lupus With Thalidomide
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Inactive SLE With Standard Dose of HCQ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inactive SLE With Reduced Dose of HCQ
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SLE/Cutaneous Lupus With Thalidomide
n=20 participants at risk
SLE/cutaneous lupus with thalidomide arm (12 months).
|
Inactive SLE With Standard Dose of HCQ
n=41 participants at risk
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed full 2016-AAO dose of HCQ (4-5.5 mg/kg/day, real body weight).
|
Inactive SLE With Reduced Dose of HCQ
n=32 participants at risk
Lupus nephritis patients on stable inactive disease for at least 6 months prescribed reduced 2016-AAO dose of HCQ (2-3.0 mg/kg/day, real body weight).
|
|---|---|---|---|
|
Nervous system disorders
Only sensory peripheral neuropathy
|
60.0%
12/20 • Number of events 12 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/32 • 12 months
|
Additional Information
Prof Eloisa Bonfa
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Phone: 551130617490
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place