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

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02786563
• Other study ID #: P15-074
• Status: Withdrawn
• Start date: September 30, 2018
• Est. completion date: November 21, 2018

Study information

• Verified date: November 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis (RA)

Locations

Country	Name	City	State
China	Hosp Ppl Liberation Army 301 /ID# 148962	Beijing
China	Peking University Peoples Hospit /ID# 148961	Beijing	Beijing
China	Renji Hosp, Shanghai Jiaotong /ID# 148959	Shanghai
China	Xijing Hospital /ID# 148960	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP.		Baseline (Week 0) to Week 20
Secondary	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
Secondary	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

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