Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence

PHASE4CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

February 29, 2004

Primary Completion Date

December 31, 2004

Study Completion Date

April 30, 2005

Conditions
Psoriasis
Interventions
DRUG

Cyclosporins

Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.

DRUG

Retinoids

Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.

DRUG

Systemic corticosteroids

Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.

DRUG

Methotrexate

Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.

DRUG

Systemic corticosteroids/methotrexate

Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT01079988 - Study of Therapeutic Options for Subjects Discontinuing Efalizumab and Experiencing Disease Recurrence | Biotech Hunter | Biotech Hunter