Additional identifiers
EudraCT number
2007-004757-28
ClinicalTrials.gov number
NCT01106079
Protocol/serial number
5221
Study information
Scientific title
A randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis
Acronym
TICOPA
Study hypothesis
Tight control versus standard care of early psoriatic arthritis (less than 24 months disease duration).
Ethics approval
Northern and Yorkshire Research Ethics Committee (REC), 01/02/2008, ref: 07/H0903/72
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
Primary outcome measures
The percentage of study patients achieving an ACR 20 response at 12 months.
Secondary outcome measures
Changes in clinical response over 6 and 12 months
Overall trial start date
01/05/2008
Overall trial end date
01/01/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Consultant diagnosis of psoriatic arthritis (PsA)
2. Disease duration less than 24 months
3. Active disease
4. Ages greater than 18 years, either sex
5. Able to consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 206; UK Sample Size: 206
Participant 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
Recruitment start date
01/05/2008
Recruitment end date
01/01/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
-
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Arthritis Research UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Pfizer UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23517506
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26433318
Publication citations
-
Protocol
Coates LC, Navarro-Coy N, Brown SR, Brown S, McParland L, Collier H, Skinner E, Law J, Moverley A, Pavitt S, Hulme C, Emery P, Conaghan PG, Helliwell PS, The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis., BMC Musculoskelet Disord, 2013, 14, 101, doi: 10.1186/1471-2474-14-101.
-
Results
Coates LC, Moverley AR, McParland L, Brown S, Navarro-Coy N, O'Dwyer JL, Meads DM, Emery P, Conaghan PG, Helliwell PS, Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial, Lancet, 2015, doi: 10.1016/S0140-6736(15)00347-5.