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Early RA MRI Early Intensive Treatment Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Lai-Shan Tam, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01762176
First received: January 4, 2013
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA), namely the delayed usual care and early intensive care, in Hong Kong.

  • The delayed usual care reflects the usual treatment practice in Hong Kong
  • The early intensive care includes tight monitoring and immediate adjustment of therapy

Condition Intervention
Early Rheumatoid Arthritis
Procedure: Protocolized intensive treatment
Procedure: Usual care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • The proportion of patients who achieve clinical remission [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)


Secondary Outcome Measures:
  • Change in various patient-reported outcomes [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The various patient-reported outcomes include employment status, Working Ability Index (WAI), disability index of Health Assessment Questionnaire (HAQ), Functional Assessment of Chronic Illness Therapy (FACIT), Hospital Anxiety and Depression Scale (HADS) and Health-related quality of life (HRQoL) generic measures

  • Gains in utility [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The Utility score is calculated by EQ-5D self-report questionnaire, which provides a single index value for health status that can be used in the clinical and economic appraisal. Value set derived from a Chinese cohort in Beijing is used, since no value set for Hong Kong Chinese population is available.

  • Radiographic progression [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Radiographic progression expressed using the van der Hejide modification of the Sharp scored

  • ACR 20, 50, 70 responses [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The ACR 20, 50, 70 responses are defined as at least 20%, 50%, 70% improvement in joint swelling and joint tenderness counts, and at least three of five other variables (i.e. erythrocyte sedimentation rate, HAQ score, pain score, and physicians' and patients' global assessments)

  • MRI outcome [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    MRI image set is evaluated and scored separately for the presence or absence of MRI erosion, synovitis, and bone marrow oedema. Bone erosions and bone marrow oedema are evaluated separately in each wrist bone, whereas synovitis is evaluated in the three regions of the wrist joint: the radioulnar area, the radiocarpal area, and the intercarpal-carpometacarpal area.


Estimated Enrollment: 200
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care group
Usual care
Procedure: Usual care
Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice
Active Comparator: Intensive care group
Protocolized intensive treatment
Procedure: Protocolized intensive treatment
Intensive treatment is defined as early diagnosis, frequent assessment (monthly) of disease activity that guides treatment change with the aim to achieve clinical remission based on a tight control protocol

Detailed Description:

This study is a 1-year non-randomized clinical trial. Two groups of patients (delayed usual care and early intensive care) with diagnosis of rheumatoid arthritis (RA) and with symptoms onset of less than 2 years and disease modifying anti-rheumatic drugs (DMARDs) naive will be recruited. Remission is reached if patients fulfill the Boolean criteria.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For usual care group:

  • patients with at least 1 tender and swollen joint
  • duration of symptoms less than 2 years
  • no previous use of DMARDs

For intensive care group:

  • patients with at least 1 tender and swollen joint
  • duration of symptoms less than 2 years
  • no previous use of DMARDs
  • patients who fulfill the 2010 ACR/EULAR classification criteria for RA

Exclusion Criteria:

  • patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m^2)
  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: NCT01762176

Contacts
Contact: Lai Shan Tam, MD 00852-2632 3996 lstam@cuhk.edu.hk

Locations
China
Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Lai Shan Tam, MD    00852-2632 3996    lstam@cuhk.edu.hk   
Principal Investigator: Lai Shan Tam, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Lai Shan Tam, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Lai-Shan Tam, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01762176     History of Changes
Other Study ID Numbers: ERA-MRI-2012
Study First Received: January 4, 2013
Last Updated: September 10, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Early Rheumatoid Arthritis
Usual care
Intensive Care
Boolean criteria

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014