Intensive management versus standard care in early psoriatic arthritis

ISRCTN	ISRCTN30147736
DOI	https://doi.org/10.1186/ISRCTN30147736
ClinicalTrials.gov (NCT)	NCT01106079
Clinical Trials Information System (CTIS)	2007-004757-28
Protocol serial number	5221
Sponsor	University of Leeds (UK)
Funders	Arthritis Research UK, Pfizer UK

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Ms Nuria Navarro Coy
Scientific

Senior Trial Manager
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis
Study acronym	TICOPA
Study objectives	Tight control versus standard care of early psoriatic arthritis (less than 24 months disease duration).
Ethics approval(s)	Northern and Yorkshire Research Ethics Committee (REC), 01/02/2008, ref: 07/H0903/72
Health condition(s) or problem(s) studied	Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention	A total of 206 patients will be randomised on an equal basis to receive either intensive management (4 weekly review) or standard care (12 weekly review). Each patient will participate in the study for 48 weeks. Those subjects randomised to the tight control arm will be reviewed every 4 weeks (by the PI 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. Follow up length: 12 months Study entry: Single Randomisation only
Intervention type	Other
Primary outcome measure(s)	The percentage of study patients achieving an ACR 20 response at 12 months
Key secondary outcome measure(s)	Changes in clinical response over 6 and 12 months
Completion date	01/01/2013

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	118
Key inclusion criteria	1. Consultant diagnosis of psoriatic arthritis (PsA) 2. Disease duration less than 24 months 3. Active disease 4. Aged over 18 years, either sex 5. Able to consent
Key exclusion criteria	1. Previous treatment with disease modifying anti-rheumatic drugs (DMARDs) for PsA 2. Under the age of 18 years 3. Pregnant women or planning pregnancy 4. Recent use of investigational drug
Date of first enrolment	01/05/2008
Date of final enrolment	01/01/2013

University of Leeds

Leeds
LS2 9JT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/12/2015		Yes	No
Results article	results	01/10/2017		Yes	No
Protocol article	protocol	21/03/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

14/07/2017: Publication reference added.
01/02/2016: Publication reference added.