TIght COntrol of Psoriatic Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

July 31, 2012

Study Completion Date

January 31, 2013

Conditions
Psoriatic Arthritis
Interventions
DRUG

Intensive management or Tight control

Those subjects randomised to the intensive management or tight control arm will be reviewed every 4 weeks (by the Principal Investigator at each site or a designated researcher) and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached.

DRUG

Standard management - Control group

The control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions.

Trial Locations (3)

LS7 4SA

Chapel Allerton Hospital, Leeds

Unknown

St Luke's Hospital, Bradford

York District Hospital, York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Arthritis Research UK

OTHER

collaborator

Pfizer

INDUSTRY

lead

Julia Brown

OTHER