Trial Outcomes & Findings for Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy (NCT NCT00368654)

Results Overview

(PASI) - given by numerical score, the index shows the severity of psoriasis.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

16 vs. 36 weeks, depending on study arm

Results posted on

2018-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	A-Monotherapy With Raptiva Alone Monotherapy with Raptiva alone Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	B-Combination Therapy With Both Raptiva and Methotrexate Combination therapy with both Raptiva and Methotrexate Methotrexate: Initial dose 5 mg, then 15 mg per week Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	C-Continue Raptiva, Discontinue Methotrexate Continue Raptiva, discontinue methotrexate Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	D-Continue Combination Therapy With Both Raptiva and Methotrex Continue combination therapy with both Raptiva and Methotrexate Methotrexate: Initial dose 5 mg, then 15 mg per week Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Overall Study STARTED	3	3	3	3
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	3	3	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A-Monotherapy With Raptiva Alone n=3 Participants Monotherapy with Raptiva alone Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	B-Combination Therapy With Both Raptiva and Methotrexate n=3 Participants Combination therapy with both Raptiva and Methotrexate Methotrexate: Initial dose 5 mg, then 15 mg per week Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	C-Continue Raptiva, Discontinue Methotrexate n=3 Participants Continue Raptiva, discontinue methotrexate Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	D-Continue Combination Therapy With Both Raptiva and Methotrex n=3 Participants Continue combination therapy with both Raptiva and Methotrexate Methotrexate: Initial dose 5 mg, then 15 mg per week Raptiva: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	Total n=12 Participants Total of all reporting groups
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	NA years STANDARD_DEVIATION NA • n=21 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants	NA Participants n=4 Participants	NA Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	12 participants n=21 Participants

PRIMARY outcome

Timeframe: 16 vs. 36 weeks, depending on study arm

Population: data not collected

(PASI) - given by numerical score, the index shows the severity of psoriasis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 vs. 36 weeks, depending on study arm

Population: Data not collected

measured by whether or not AE was serious

Outcome measures

Outcome data not reported

Adverse Events

A-Monotherapy With Raptiva Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B-Combination Therapy With Both Raptiva and Methotrexate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

C-Continue Raptiva, Discontinue Methotrexate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

D-Continue Combination Therapy With Both Raptiva and Methotrex

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chai Sue Lee

Kaiser Permanente (Current), UC Davis (Previous)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place