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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02786563
Other study ID # P15-074
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


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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