Trial Outcomes & Findings for Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept (NCT NCT00927069)
NCT ID: NCT00927069
Last Updated: 2011-09-09
Results Overview
Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
COMPLETED
PHASE3
85 participants
12 weeks
2011-09-09
Participant Flow
Participant milestones
| Measure |
Group A
Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
|
Group B
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Groupe A Dose Increase at Week 12
Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
|
Groupe B Dose Increase at Week 12
Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
|
|---|---|---|---|---|
|
Week 0 to Week 12
STARTED
|
50
|
35
|
0
|
0
|
|
Week 0 to Week 12
COMPLETED
|
49
|
34
|
0
|
0
|
|
Week 0 to Week 12
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Week 12 to Week 24
STARTED
|
18
|
11
|
31
|
23
|
|
Week 12 to Week 24
COMPLETED
|
16
|
11
|
28
|
20
|
|
Week 12 to Week 24
NOT COMPLETED
|
2
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Group A
Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
|
Group B
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Groupe A Dose Increase at Week 12
Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
|
Groupe B Dose Increase at Week 12
Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
|
|---|---|---|---|---|
|
Week 0 to Week 12
Worsening of psoriasis
|
1
|
1
|
0
|
0
|
|
Week 12 to Week 24
Lack of Efficacy
|
0
|
0
|
2
|
3
|
|
Week 12 to Week 24
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Week 12 to Week 24
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Week 12 to Week 24
Had a vaccination, removed from study
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Adalimumab in Patients Who Showed an Unsatisfactory Response to Etanercept
Baseline characteristics by cohort
| Measure |
Group A
n=50 Participants
Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
|
Group B
n=35 Participants
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age Continuous
|
49.12 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
46.17 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
47.91 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=5 Participants
|
35 participants
n=7 Participants
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Efficacy of adalimumab 40 mg every other week in patients in Group B by calculating the number of patients who achieve a PGA of clear or almost clear at Week 12. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Outcome measures
| Measure |
Group B
n=35 Participants
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Group B
Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
|
|---|---|---|
|
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at week 12. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Outcome measures
| Measure |
Group B
n=50 Participants
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Group B
Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
|
|---|---|---|
|
Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12.
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Efficacy of adalimumab in patients from Group B who achieve a Physician's global assessment (PGA) of clear or almost clear at Week 24. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Outcome measures
| Measure |
Group B
n=23 Participants
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Group B
Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
|
|---|---|---|
|
Number of Patients From Group B Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Efficacy of adalimumab in patients from Group A who achieve a Physician's Global Assessment (PGA) of clear or almost clear at Week 24. Clear is defined by no plaque elevation above normal skin. There is no scale. Erythema is perceptible as hyperpigmentation, pigmented macules, diffuse faint pink or red coloration. Almost Clear is defined as follows: It is possible but difficult to ascertain whether there is a slight elevation above normal skin. There is scaling in the form of surface dryness with some white coloration. Erythema is up to a difinite red coloration.
Outcome measures
| Measure |
Group B
n=31 Participants
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Group B
Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
|
|---|---|---|
|
Number of Patients From Group A Who Achieve a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 24 After a Dose Increase to 40mg Adalimumab Every Week.
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The analysis was intent to treat (ITT) and inputed Last observation carried forward (LOCF)
Safety of adalimumab in patients with plaque psoriasis that showed an unsatisfactory response after at least 3 months of therapy with etanercept
Outcome measures
| Measure |
Group B
n=50 Participants
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
Group B
n=35 Participants
Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
|
|---|---|---|
|
Total Number of Adverse Events for All Patients in the Study.
|
91 Adverse events
|
63 Adverse events
|
Adverse Events
Group A
Group B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=50 participants at risk
Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening.
|
Group B
n=35 participants at risk
Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
|
|---|---|---|
|
Infections and infestations
Common Cold
|
8.0%
4/50 • Number of events 5 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
5.7%
2/35 • Number of events 2 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
|
Nervous system disorders
Headache
|
0.00%
0/50 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
11.4%
4/35 • Number of events 4 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
18.0%
9/50 • Number of events 12 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
5.7%
2/35 • Number of events 3 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
|
Infections and infestations
Sinusitis
|
6.0%
3/50 • Number of events 3 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
0.00%
0/35 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.0%
4/50 • Number of events 7 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
0.00%
0/35 • The period in which adverse events were recorded was between the signing of the informed consent at screening and Week 28 (approximately 32 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60