Clinical trial NCT02786563: Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate
Official title: Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis (RA)
Keywords: power doppler (PD)
ultrasonographic (US)
rheumatoid arthritis (RA)
disease activity scale (DAS)
C-reactive protein (CRP)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving adalimumab with Rheumatoid Arthritis (RA) in China

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in grey-scale (GS) scores
timeFrame: Week 0 (baseline) and Week 12
measure: Change in power Doppler (PD) semi-quantitative scores from baseline
timeFrame: Week 0 (baseline) and Week 12
measure: 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.
timeFrame: Week 0 (baseline) and Week 12
Secondary outcomes:
measure: Change from baseline in counts of joints with US detected bone erosion
timeFrame: Baseline (Week 0) to Week 12
measure: Percentage of participants achieving low disease activity
timeFrame: Baseline (Week 0) to Week 12 and Week 20
measure: Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP.
timeFrame: Baseline (Week 0) to Week 20
measure: Percentage of patients achieving clinical remission
timeFrame: Baseline (Week 0) to Week 12 and Week 20
measure: Change in DAS 28-CRP from baseline
timeFrame: Baseline (Week 0) to Week 12 and Week 20
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Peoples Hospit /ID# 148961
state: Beijing
city: Xian
country: China
facility: Xijing Hospital /ID# 148960
state: Shaanxi
city: Beijing
country: China
facility: Hosp Ppl Liberation Army 301 /ID# 148962
city: Shanghai
country: China
facility: Renji Hosp, Shanghai Jiaotong /ID# 148959
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: