NCT02786563

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

May 26, 2016

Last Update Submit

November 21, 2018

Conditions

Rheumatoid Arthritis (RA)

Keywords

power doppler (PD)ultrasonographic (US)rheumatoid arthritis (RA)disease activity scale (DAS)C-reactive protein (CRP)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Change from baseline in counts of joints with US detected bone erosion

    Baseline (Week 0) to Week 12

  • Percentage of participants achieving low disease activity

    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

    Baseline (Week 0) to Week 12 and Week 20

  • Change in DAS 28-CRP from baseline

    Baseline (Week 0) to Week 12 and Week 20

Study Arms (1)

Participants with RA receiving adalimumab

This group contains participants in China with RA receiving adalimumab

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants receiving adalimumab with Rheumatoid Arthritis (RA) in China

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Peking University Peoples Hospit /ID# 148961

Beijing, Beijing Municipality, 100044, China

Location

Xijing Hospital /ID# 148960

Xi'an, Shaanxi, 710032, China

Location

Hosp Ppl Liberation Army 301 /ID# 148962

Beijing, 100034, China

Location

Renji Hosp, Shanghai Jiaotong /ID# 148959

Shanghai, 200127, China

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 1, 2016

Study Start

September 30, 2018

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations

CN(4)