Trial Outcomes & Findings for Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE) (NCT NCT00633945)
NCT ID: NCT00633945
Last Updated: 2023-02-09
Results Overview
The Cutaneous Lupus Area and Severity Index (CLASI); range of disease activity is 0-70. Lower scores reflect less activity.
COMPLETED
NA
5 participants
Weeks 0 through 52
2023-02-09
Participant Flow
The sample size was determined by the number of study subjects for whom Celgene Corporation was willing to supply medication during and beyond the study period. It was felt that 5 study subjects would provide valuable information about the responsiveness of severe CLE to lenalidomide (REVLIMID®) and subjects' tolerability to the study medication.
Participant milestones
| Measure |
Lenalidomide
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Lenalidomide
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Evaluation of Lenalidomide (REVLIMID®) to Treat Subjects With Cutaneous Lupus Erythematosus (CLE)
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 4.82 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Weeks 0 through 52Population: Two patients were not included at week 52 because one did not respond and one had new onset proteinuria and arthralgias.
The Cutaneous Lupus Area and Severity Index (CLASI); range of disease activity is 0-70. Lower scores reflect less activity.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Cutaneous Lupus Area and Severity Index (CLASI)
0 weeks
|
21.4 units on a scale
Interval 16.0 to 26.0
|
—
|
|
Cutaneous Lupus Area and Severity Index (CLASI)
6 weeks
|
10.8 units on a scale
Interval 8.0 to 18.0
|
—
|
|
Cutaneous Lupus Area and Severity Index (CLASI)
12 weeks
|
8.6 units on a scale
Interval 1.0 to 18.0
|
—
|
|
Cutaneous Lupus Area and Severity Index (CLASI)
52 weeks
|
5.3 units on a scale
Interval 0.0 to 12.0
|
—
|
SECONDARY outcome
Timeframe: 6 weeksCXCL10, an interferon-inducible chemokine, and immunophenotyping by immunostaining. Measurement of interferon-inducible genes from peripheral blood mononuclear cells before and after treatment.
Outcome measures
| Measure |
Lenalidomide
n=4 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
n=1 Participants
Lack of response with CLASI
|
|---|---|---|
|
Number of Participants With Change in IFN and CD4 Levels at 6 Weeks
IFN score decrease
|
4 Participants
|
1 Participants
|
|
Number of Participants With Change in IFN and CD4 Levels at 6 Weeks
CD4 decrease
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Weeks 0 through 52Population: 5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.
General skin scores were recorded on a 10 cm visual analogue scale at each visit. At each visit on scale 0-10, 0 corresponding to worst skin condition imaginable and 10 to perfect health.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Physician Global Assessment (PGA) for Skin
week 0
|
6 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Physician Global Assessment (PGA) for Skin
week 6
|
3 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Physician Global Assessment (PGA) for Skin
week 12
|
3.8 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Physician Global Assessment (PGA) for Skin
week 52
|
2 units on a scale
Interval 0.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 through 52Population: 5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.
General skin scores were recorded by the patient on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to worst skin condition imaginable and 10 to perfect health.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Patient General Assessment (PtGA) for Skin
week 0
|
5.6 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient General Assessment (PtGA) for Skin
week 6
|
3.6 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient General Assessment (PtGA) for Skin
week 12
|
4.2 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Patient General Assessment (PtGA) for Skin
week 52
|
0.8 units on a scale
Interval 0.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 through 52Population: 5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.
Pain in skin was recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no pain and 10 to pain as bad as you can imagine.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Pain in Skin
week 0
|
4.5 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Pain in Skin
week 6
|
2 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Pain in Skin
week 12
|
2.5 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Pain in Skin
week 52
|
0.5 units on a scale
Interval 0.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 through 52Population: 5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.
Itch scores were recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no itch and 10 to itch as bad as you can imagine.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Itch in Skin
week 52
|
0 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Itch in Skin
week 0
|
4.0 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Itch in Skin
week 6
|
1.2 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Itch in Skin
week 12
|
2.25 units on a scale
Interval 0.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 through 52Population: 5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.
Fatigue scores were recorded on a 10 cm visual analogue scale at each visit by the patient. At each visit on scale 0-10, 0 corresponding to no fatigure and 10 to fatigue as bad as you can imagine.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Fatigue
week 0
|
7.25 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Fatigue
week 6
|
3.4 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Fatigue
week 12
|
5.25 units on a scale
Interval 0.0 to 10.0
|
—
|
|
Fatigue
week 52
|
3 units on a scale
Interval 0.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 through 52Population: 5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.
Skindex symptoms scores are scored 1-5 and then normalized to 100, with a higher score corresponding to a worse impression. The absence of symptom impact on QoL is scored as "20" (this is represented as a 1 on the 1-5 scale. The worst impact of symptoms on QoL is 100. This is represented as a 5 on the 1-5 scale.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Skindex Symptoms
week 0
|
58.5 units on a scale
Interval 0.0 to 100.0
|
—
|
|
Skindex Symptoms
week 6
|
41.82 units on a scale
Interval 0.0 to 100.0
|
—
|
|
Skindex Symptoms
week 12
|
36.4 units on a scale
Interval 0.0 to 100.0
|
—
|
|
Skindex Symptoms
week 52
|
12.5 units on a scale
Interval 0.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Weeks 0 through 52Population: 5 patients until week 12, 3 patients to week 52. Dropout prevented proper analysis of week 12 to 52.
Skindex function scores are scored 1-5 and then normalized to 100, with a higher score corresponding to a worse impression. The absence of function impact on QoL is scored as "20" (this is represented as a 1 on the 1-5 scale. The worst impact of function on QoL is 100. This is represented as a 5 on the 1-5 scale.
Outcome measures
| Measure |
Lenalidomide
n=5 Participants
Patients took 5 mg daily of oral lenalidomide for the initial 6 weeks. Patients who had responded at 6 weeks lowered their dose to 5 mg every other day, while non-responders were increased to a dose of 10 mg daily.
|
Lenalidomide Nonresponder
Lack of response with CLASI
|
|---|---|---|
|
Skindex Function
week 0
|
41.26 units on a scale
Interval 0.0 to 100.0
|
—
|
|
Skindex Function
week 6
|
30.42 units on a scale
Interval 0.0 to 100.0
|
—
|
|
Skindex Function
week 12
|
29.2 units on a scale
Interval 0.0 to 100.0
|
—
|
|
Skindex Function
week 52
|
4.2 units on a scale
Interval 0.0 to 100.0
|
—
|
Adverse Events
Group 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place