Rheumatoid Arthritis (RA)NCT02786563
Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate
An observational study of Rheumatoid Arthritis (RA), run by AbbVie at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 0 participants
- Where
- 4 sitesChina
- Study dates
- 30 Sep 2018to 21 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants receiving adalimumab with Rheumatoid Arthritis (RA) in China
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Peking University Peoples Hospit /ID# 148961
Beijing, Beijing Municipality, 100044
Hosp Ppl Liberation Army 301 /ID# 148962
Beijing, 100034
Renji Hosp, Shanghai Jiaotong /ID# 148959
Shanghai, 200127
Xijing Hospital /ID# 148960
Xi'an, Shaanxi, 710032
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- power doppler (PD), ultrasonographic (US), rheumatoid arthritis (RA), disease activity scale (DAS), C-reactive protein (CRP)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with RA receiving adalimumab | This group contains participants in China with RA receiving adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in grey-scale (GS) scores
Change in GS scores from baseline at Week 12, using 36-joint scoring system
Measured: 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
Measured: 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.
Measured: Week 0 (baseline) and Week 12
Secondary outcomes (5)
Change from baseline in counts of joints with US detected bone erosion
The change in counts of joints with US detected bone erosion.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline (Week 0) to Week 12 and Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start30 Sep 2018 (estimated)
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786563
- Sponsor's protocol ID
- P15-074
- Status last verified
- Nov 2018
- First submitted
- 26 May 2016
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
- ClinicalTrials.gov ID
- NCT02786563
- Acronym / sponsor ID
- P15-074
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- power doppler (PD), ultrasonographic (US), rheumatoid arthritis (RA), disease activity scale (DAS), C-reactive protein (CRP)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Strategic considerations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2018 (estimated)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with RA receiving adalimumab | – | –This group contains participants in China with RA receiving adalimumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants receiving adalimumab with Rheumatoid Arthritis (RA) in China
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in grey-scale (GS) scores
Time frame: Week 0 (baseline) and Week 12
Change in GS scores from baseline at Week 12, using 36-joint scoring system
Change in power Doppler (PD) semi-quantitative scores from baseline
Time frame: Week 0 (baseline) and Week 12
Change in PD semi-quantitative scores from baseline at week 12, using 36-joint scoring system
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.
Time frame: Week 0 (baseline) and Week 12
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.
5 secondary outcomes
Change from baseline in counts of joints with US detected bone erosion
Time frame: Baseline (Week 0) to Week 12
Percentage of participants achieving low disease activity
Time frame: 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.
Time frame: Baseline (Week 0) to Week 20
Percentage of patients achieving clinical remission
Time frame: Baseline (Week 0) to Week 12 and Week 20
Change in DAS 28-CRP from baseline
Time frame: Baseline (Week 0) to Week 12 and Week 20
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by AbbVie at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in grey-scale (GS) scores (time frame: Week 0 (baseline) and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.