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TIght COntrol of Psoriatic Arthritis (TICOPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01106079
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : May 28, 2015
Sponsor:
Collaborators:
Arthritis Research UK
Pfizer
Information provided by (Responsible Party):
Julia Brown, University of Leeds

Tracking Information
First Submitted Date  ICMJE April 15, 2010
First Posted Date  ICMJE April 19, 2010
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE May 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2010)
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TIght COntrol of Psoriatic Arthritis
Official Title  ICMJE A Randomised Controlled Trial to Compare Intensive Management vs Standard Care in Early Psoriatic Arthritis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intensive management
    Intervention: Drug: Intensive management or Tight control
  • Active Comparator: Standard management
    Intervention: Drug: Standard management - Control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2010)
206
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01106079
Other Study ID Numbers  ICMJE RR07/8350
2007-004757-28 ( EudraCT Number )
18825 ( Other Grant/Funding Number: Arthritis Research UK )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julia Brown, University of Leeds
Study Sponsor  ICMJE Julia Brown
Collaborators  ICMJE
  • Arthritis Research UK
  • Pfizer
Investigators  ICMJE
Principal Investigator: Philip Helliwell University of Leeds
PRS Account University of Leeds
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP