TIght COntrol of Psoriatic Arthritis

NCT01106079 | Completed Phase 3 DMC

• 3 other identifiers: RR07/83502007-004757-2818825
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to investigate whether tight control of patients with newly diagnosed psoriatic arthritis (consisting of regular 4 weekly objective assessment of disease activity and protocol-led intensive treatment) can improve outcome as opposed to standard care (usually 3 monthly reviews with no objective outcome measures and no protocol for treatment). The principle hypothesis of this study is that tight control of inflammation in psoriatic arthritis using a treatment protocol and pre-defined objective targets for treatment will lead to an improvement in patients' disease activity and a reduction in radiological joint damage.

Conditions

Psoriatic Arthritis

Keywords

Early psoriatic arthritis; Tight control; Intensive management

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving an ACR20 response.

  To compare intensive management with standard care in terms of the proportion of patients achieving an ACR20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy.

  48 weeks

Secondary Outcomes (9)

• Additional clinical efficacy outcomes

  24 weeks

• Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL

  24 weeks

• To compare intensive management with standard care in terms of cost effectiveness

  12 weeks

• Number of participants with adverse events as a measure of safety and tolerability

  From baseline until 52 weeks

• Imaging efficacy: PsAMRIS and ultrasound assessment of disease

  48 weeks

Study Arms (2)

Intensive management

EXPERIMENTAL

Drug: Intensive management or Tight control

Standard management

ACTIVE COMPARATOR

Drug: Standard management - Control group

Interventions

Intensive management or Tight control DRUG

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.

Intensive management

Standard management - Control group DRUG

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.

Standard management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of psoriatic arthritis by a consultant Rheumatologist with less than 24 months disease duration.
• Active disease defined by at least one tender or swollen joint or active enthesitis.
• Age ≥18 years at the time of signing the informed consent form and either male or female patients.
• Patient understands the objectives of the study and is able and willing to sign the Informed Consent Form.
• Men and women of child bearing potential (WCBP) must use at least one adequate birth control measure for the duration of the study and should continue such precautions for 6 months after receiving the last dose of protocol treatment.
• Adequate full blood count within 28 days before randomisation:
• Haemoglobin count \> 8.5 g/dL
• White blood count (WBC) \> 3.5 x 10\*9/L
• Absolute neutrophil count (ANC) \> 1.5 x 10\*9/L
• Platelet count \> 100 x 10\*9/L
• Adequate hepatobiliary function within 28 days before randomisation:
• \*ALT and/or AST levels must be within 3 times the upper limit of normal range (ULN) for the laboratory conducting the test.
• The patient must be able to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

• Previous treatment for articular disease with disease modifying drugs (DMARDs) including, but not limited to, methotrexate, sulfasalazine, leflunomide,
• Women who are pregnant, lactating or planning pregnancy within 6 months of their last dose of protocol treatment.
• Use of any investigational agents within 4 weeks or within 5 half-lives of the investigational agent, whichever is longer, prior to randomisation.

Sponsors & Collaborators

• Julia Brown: lead
• Arthritis Research UK: collaborator
• Pfizer: collaborator

Study Sites (3)

Chapel Allerton Hospital

Leeds, West Yorkshire, LS7 4SA, United Kingdom

Location

St Luke's Hospital

Bradford, United Kingdom

Location

York District Hospital

York, United Kingdom

Location

Related Publications (5)

• Coates LC, Mahmood F, Emery P, Conaghan PG, Helliwell PS. The dynamics of response as measured by multiple composite outcome tools in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial. Ann Rheum Dis. 2017 Oct;76(10):1688-1692. doi: 10.1136/annrheumdis-2017-211137. Epub 2017 Jun 12.

  PMID: 28606970 DERIVED

• O'Dwyer JL, Meads DM, Hulme CT, Mcparland L, Brown S, Coates LC, Moverley AR, Emery P, Conaghan PG, Helliwell PS. Cost-Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Mar;70(3):462-468. doi: 10.1002/acr.23293. Epub 2018 Jan 30.

  PMID: 28544822 DERIVED

• 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 Dec 19;386(10012):2489-98. doi: 10.1016/S0140-6736(15)00347-5. Epub 2015 Oct 1.

  PMID: 26433318 DERIVED

• Freeston JE, Coates LC, Nam JL, Moverley AR, Hensor EM, Wakefield RJ, Emery P, Helliwell PS, Conaghan PG. Is there subclinical synovitis in early psoriatic arthritis? A clinical comparison with gray-scale and power Doppler ultrasound. Arthritis Care Res (Hoboken). 2014 Mar;66(3):432-9. doi: 10.1002/acr.22158.

  PMID: 24022986 DERIVED

• 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 Mar 21;14:101. doi: 10.1186/1471-2474-14-101.

  PMID: 23517506 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Philip Helliwell

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of CTRU

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 19, 2010
• Study Start: May 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

GB (3)