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Completed

NCT Number: NCT01762176

Early RA MRI Early Intensive Treatment Study

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

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Key information

Conditions

Early Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Protocolized intensive treatment

Procedure

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

usual care

Procedure

Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice

Primary outcomes

  1. The proportion of patients who achieve clinical remission

    Time frame: 12 months

    The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)

Secondary outcomes

  1. Change in various patient-reported outcomes

    Time frame: 12 months

    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

  2. Gains in utility

    Time frame: 12 months

    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.

  3. Radiographic progression

    Time frame: 12 months

    Radiographic progression expressed using the van der Hejide modification of the Sharp scored

  4. ACR 20, 50, 70 responses

    Time frame: 12 months

    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)

  5. MRI outcome

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2013
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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