Intensive management versus standard care in early psoriatic arthritis
| ISRCTN | ISRCTN30147736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30147736 |
| EudraCT/CTIS number | 2007-004757-28 |
| ClinicalTrials.gov number | NCT01106079 |
| Secondary identifying numbers | 5221 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 14/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Nuria Navarro Coy
Scientific
Scientific
Senior Trial Manager
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/05/2008 |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 206; UK Sample Size: 206 |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Leeds
LS2 9JT
United Kingdom
LS2 9JT
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
-
Leeds
LS2 9JT
England
United Kingdom
| Website | http://www.leeds.ac.uk |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Industry
Arthritis Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Pfizer UK
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Ltd, Pfizer Limited
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/03/2013 | Yes | No | |
| Results article | results | 19/12/2015 | Yes | No | |
| Results article | results | 01/10/2017 | Yes | No |
Editorial Notes
14/07/2017: Publication reference added.
01/02/2016: Publication reference added.
