TIght COntrol of Psoriatic Arthritis (TICOPA)

May 27, 2015 updated by: Julia Brown

A Randomised Controlled Trial to Compare Intensive Management vs Standard Care in Early Psoriatic Arthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The TICOPA trial is designed as a randomised, controlled, parallel group, open label, multi-centre clinical trial of 206 patients with recent onset psoriatic arthritis. Patients will be randomised on a 1:1 basis to receive either standard care (12 weekly review) or tight control (4 weekly review) for a period of 48 weeks. The hypothesis is that tight control of inflammation will lead to a better outcome in terms of joint inflammation, joint damage, pain and quality of life for people with PsA. This imaging undertaken within the study will provide a further measure of joint inflammation and damage and will improve understanding of the relationships between inflammation, damage and bony proliferation in psoriatic arthritis.

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, 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. 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.

All subjects will be treated and followed-up for 48 weeks from randomisation according to their treatment allocation and will have 12 weekly clinical disease assessments throughout this period by a fully trained, blinded assessor. This will include measures of disease activity in all of the five aspects of PsA (joint disease, skin disease, enthesitis, dactylitis and spinal disease).

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bradford, United Kingdom
        • St Luke's Hospital
      • York, United Kingdom
        • York District Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS7 4SA
        • Chapel Allerton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive management
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.
Active Comparator: Standard management
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients achieving an ACR20 response.
Time Frame: 48 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional clinical efficacy outcomes
Time Frame: 24 weeks

To compare intensive management with standard care in terms of additional clinical efficacy outcomes at 24 and 48 weeks, including:

  • ACR20 (24 weeks), ACR50 and ACR70
  • PASI 20, PASI 75 and PASI 90
  • Change in Sharp-van der Heijde Score
  • ASAS 20 and ASAS 40
  • Change in enthesitis score
  • Change in dactylitis score
  • Change in mNAPSI
  • Change in HAQ
  • Change in other scores (including BASDAI, tender and swollen joint counts, patient and clinician VAS scores)
  • MDA score
24 weeks
Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL
Time Frame: 24 weeks
To compare intensive management with standard care in terms of Quality of Life (QoL),using PsAQoL between intensive management and standard care at baseline, 24 and 48 weeks
24 weeks
To compare intensive management with standard care in terms of cost effectiveness
Time Frame: 12 weeks
To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks
12 weeks
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: From baseline until 52 weeks
To compare intensive management with standard care in terms of safety outcomes over the course of the treatment until 52 weeks
From baseline until 52 weeks
Imaging efficacy: PsAMRIS and ultrasound assessment of disease
Time Frame: 48 weeks
To compare intensive management with standard care in terms of imaging efficacy outcomes including change in Psoriatic Arthritis Magnetic Resonance Imaging Score (PsAMRIS) and ultrasound assessment of disease at 48 weeks in order to assess inflammation and damage.
48 weeks
Additional clinical efficacy outcomes
Time Frame: 48 weeks

To compare intensive management with standard care in terms of additional clinical efficacy outcomes at 24 and 48 weeks, including:

  • ACR20 (24 weeks), ACR50 and ACR70
  • PASI 20, PASI 75 and PASI 90
  • Change in Sharp-van der Heijde Score
  • ASAS 20 and ASAS 40
  • Change in enthesitis score
  • Change in dactylitis score
  • Change in mNAPSI
  • Change in HAQ
  • Change in other scores (including BASDAI, tender and swollen joint counts, patient and clinician VAS scores)
  • MDA score
48 weeks
Comparison between intensive management and standard care in terms of Quality of Life (QoL),using PsAQoL
Time Frame: 48 weeks
To compare intensive management with standard care in terms of Quality of Life (QoL),using PsAQoL between intensive management and standard care at baseline, 24 and 48 weeks.
48 weeks
To compare intensive management with standard care in terms of cost effectiveness
Time Frame: 24 weeks
To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks
24 weeks
To compare intensive management with standard care in terms of cost effectiveness
Time Frame: 48 weeks
To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julia Brown

Collaborators

Pfizer
Arthritis Research UK

Investigators

  • Principal Investigator: Philip Helliwell, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 16, 2010

First Posted (Estimate)

April 19, 2010

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RR07/8350
  • 2007-004757-28 (EudraCT Number)
  • 18825 (Arthritis Research UK)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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