Trial record 3 of 47 for:    Open Studies | "Arthritis, Psoriatic"

TIght COntrol of Psoriatic Arthritis (TICOPA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Leeds.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Arthritis Research UK
Pfizer
Information provided by:
University of Leeds
ClinicalTrials.gov Identifier:
NCT01106079
First received: April 15, 2010
Last updated: September 30, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Intensive management or Tight control
Drug: Standard management - Control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial to Compare Intensive Management vs Standard Care in Early Psoriatic Arthritis

Resource links provided by NLM:


Further study details as provided by University of Leeds:

Primary Outcome Measures:
  • Proportion of patients achieving an ACR20 response. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Additional clinical efficacy outcomes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To compare intensive management with standard care in terms of cost effectiveness at 12, 24 and 48 weeks


Estimated Enrollment: 206
Study Start Date: May 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106079

Contacts
Contact: Nuria C Navarro-Coy 00 44 113 3437792 n.navarro-coy@leeds.ac.uk

Locations
United Kingdom
Chapel Allerton Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS7 4SA
Contact: Philip Helliwell, Professor    00 44 113 392 3064    p.helliwell@leeds.ac.uk   
Principal Investigator: Philip Helliwell, Professor         
St Luke's Hospital Recruiting
Bradford, United Kingdom
Contact: Philip Helliwell, Professor    00 44 113 392 3064    p.helliwell@leeds.ac.uk   
Principal Investigator: Phillip Helliwell, Professor         
York District Hospital Recruiting
York, United Kingdom
Contact: Laura Coates, Dr    00 44 113 3924961    l.c.coates@leeds.ac.uk   
Principal Investigator: Mark Quinn, Dr         
Sponsors and Collaborators
University of Leeds
Arthritis Research UK
Pfizer
Investigators
Principal Investigator: Philip Helliwell University of Leeds
  More Information

No publications provided by University of Leeds

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ms Clare Skinner / Faculty Head of Research Support, University of Leeds
ClinicalTrials.gov Identifier: NCT01106079     History of Changes
Other Study ID Numbers: RR07/8350, 2007-004757-28, 18825
Study First Received: April 15, 2010
Last Updated: September 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Leeds:
Early psoriatic arthritis
Tight control
Intensive management

Additional relevant MeSH terms:
Arthritis, Psoriatic
Arthritis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014