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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis (RA)

• Study Type: Observational

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Hosp Ppl Liberation Army 301 /ID# 148962
  • Shanghai, China, 200127
    • Renji Hosp, Shanghai Jiaotong /ID# 148959
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University Peoples Hospit /ID# 148961
  • Shaanxi
    • Xian, Shaanxi, China, 710032
      • Xijing Hospital /ID# 148960

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants receiving adalimumab with Rheumatoid Arthritis (RA) in China

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in grey-scale (GS) scores	Change in GS scores from baseline at Week 12, using 36-joint scoring system	Week 0 (baseline) and Week 12
Change in power Doppler (PD) semi-quantitative scores from baseline	Change in PD semi-quantitative scores from baseline at week 12, using 36-joint scoring system	Week 0 (baseline) and Week 12
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.	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.	Week 0 (baseline) and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in counts of joints with US detected bone erosion	The change in counts of joints with US detected bone erosion.	Baseline (Week 0) to Week 12
Percentage of participants achieving low disease activity	The percentage of participants achieving low disease activity (LDA, DAS 28-CRP greater than or equal to 2.6 but less than 3.2).	Baseline (Week 0) to Week 12 and Week 20
Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP.		Baseline (Week 0) to Week 20
Percentage of patients achieving clinical remission	The percentage of participants achieving clinical remission (DAS 28-CRP less than 2.6).	Baseline (Week 0) to Week 12 and Week 20
Change in DAS 28-CRP from baseline	The Disease Activity Score C-Reactive Protein (DAS 28-CRP); 4 variables, using 28-joint counts and CRP.	Baseline (Week 0) to Week 12 and Week 20

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2018
• Primary Completion (Actual): November 21, 2018
• Study Completion (Actual): November 21, 2018

Study Registration Dates

• First Submitted: May 26, 2016
• First Submitted That Met QC Criteria: May 26, 2016
• First Posted (Estimate): June 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: C-reactive protein (CRP); power doppler (PD); ultrasonographic (US); rheumatoid arthritis (RA); disease activity scale (DAS)
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Inflammation
• Other Study ID Numbers: P15-074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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