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Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate

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ClinicalTrials.gov Identifier: NCT02786563
Recruitment Status : Withdrawn (Strategic considerations)
First Posted : June 1, 2016
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
Prospective, post-marketing, multi-center, open-label study to explore if the initiation of adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US) score using 36-joint plus 4-tendon scoring system, and validate the applicability of different simplified US joint scoring systems.

Condition or disease
Rheumatoid Arthritis (RA)

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Estimated Study Start Date : September 30, 2018
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Participants with RA receiving adalimumab
This group contains participants in China with RA receiving adalimumab



Primary Outcome Measures :
  1. Change from baseline in grey-scale (GS) scores [ Time Frame: Week 0 (baseline) and Week 12 ]
    Change in GS scores from baseline at Week 12, using 36-joint scoring system

  2. Change in power Doppler (PD) semi-quantitative scores from baseline [ Time Frame: Week 0 (baseline) and Week 12 ]
    Change in PD semi-quantitative scores from baseline at week 12, using 36-joint scoring system

  3. Correlation between the 36-joint plus 4-tendon assessment versus simplified joint power Doppler (PD) ultrasonographic (US) assessments, which include 12-joint/7-joint/6-joint plus 4-tendon systems. [ Time Frame: Week 0 (baseline) and Week 12 ]
    Correlation coefficients will be presented to assess the correlation between the 36-joint plus 4-tendon PDUS assessment versus the simplified 12-joint/7-joint/6-joint plus 4-tendon assessments.


Secondary Outcome Measures :
  1. Change from baseline in counts of joints with US detected bone erosion [ Time Frame: Baseline (Week 0) to Week 12 ]
    The change in counts of joints with US detected bone erosion.

  2. Percentage of participants achieving low disease activity [ Time Frame: Baseline (Week 0) to Week 12 and Week 20 ]
    The percentage of participants achieving low disease activity (LDA, DAS 28-CRP greater than or equal to 2.6 but less than 3.2).

  3. Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP. [ Time Frame: Baseline (Week 0) to Week 20 ]
  4. Percentage of patients achieving clinical remission [ Time Frame: Baseline (Week 0) to Week 12 and Week 20 ]
    The percentage of participants achieving clinical remission (DAS 28-CRP less than 2.6).

  5. Change in DAS 28-CRP from baseline [ Time Frame: Baseline (Week 0) to Week 12 and Week 20 ]
    The Disease Activity Score C-Reactive Protein (DAS 28-CRP); 4 variables, using 28-joint counts and CRP.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants receiving adalimumab with Rheumatoid Arthritis (RA) in China
Criteria

Inclusion Criteria:

  • Moderate to severe RA despite treatment with methotrexate (MTX).
  • Eligible to use adalimumab according to the local label without any contraindication.
  • Naïve to adalimumab, and participants with prior exposure to any other biologic disease-modifying antirheumatic drugs (DMARDs) should have experienced at least five half-lives of the biologics after treatment discontinuation.
  • Participants for whom investigators decided to prescribe adalimumab as per local label and are initiating adalimumab at baseline.

Exclusion Criteria:

  • Other inflammatory condition which may affect the signs on joints ultrasound (eg, gouty arthritis, or other chronic rheumatic disease besides RA).
  • Currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days of the baseline visit.
  • Participants with contraindication or are not appropriate to use adalimumab according to local label or investigators' judgment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02786563


Locations
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China, Beijing
Peking University Peoples Hospit /ID# 148961
Beijing, Beijing, China, 100044
China, Shaanxi
Xijing Hospital /ID# 148960
Xian, Shaanxi, China, 710032
China
Hosp Ppl Liberation Army 301 /ID# 148962
Beijing, China, 100034
Renji Hosp, Shanghai Jiaotong /ID# 148959
Shanghai, China, 200127
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02786563    
Other Study ID Numbers: P15-074
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
power doppler (PD)
ultrasonographic (US)
rheumatoid arthritis (RA)
disease activity scale (DAS)
C-reactive protein (CRP)
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes