ArthritisNCT01464021
A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
An observational study of Arthritis and Rheumatoid, run by AbbVie (prior sponsor, Abbott) at 3 sites in China.
Trial summary
A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 26 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2011to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
Who may be able to join
- Male or female patient greater than or equal to 18 years of age with diagnosis of RA (Rheumatoid Arthritis) and no history of chronic arthritis before age 16.
- Patient meets the requirements for treatment with adalimumab per the local product label.
- Patient is naïve to adalimumab, and has not used any other immunomodulatory biologic* DMARD (Disease Modifying Antirheumatic Drugs) in the past 8 weeks before the Baseline visit (*rituximab may not have been used in the past 104 weeks before the Baseline visit).
- Patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by Abbott.
Who cannot join
- Patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline visit.
- Prior clinically active TB (tuberculosis): if patient has had prior clinically active TB, there should be documentation that a full course of appropriate anti-TB therapy was completed or an ongoing full course of appropriate anti-TB therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study.
- Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab.
- Patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the Investigator determines that they should not be enrolled based on his/her clinical judgment.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Site Reference ID/Investigator# 64782
Guangzhou, 510080
Site Reference ID/Investigator# 65702
Shanghai, 200052
Site Reference ID/Investigator# 65706
Ürümqi, 830001
About this study
A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China.
Read the detailed description
This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered subcutaneously (SC). Adalimumab effectiveness will be assessed based on data from clinic visits beginning at Baseline and continuing per standard of care for RA. The primary objective is to evaluate the effectiveness of adalimumab in improving patients' disease activity measured by Disease Activity Score (DAS28) at Week 12. The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. The study was terminated due to low enrollment.
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Study, prospective, Rheumatoid, Observational study, Arthritis, Adalimumab
- Medical subject headings
- Arthritis
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 |
|---|---|---|
| Adalimumab | Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.
A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.
A Moderate Response is defined as either:
an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1
Measured: Week 12
Secondary outcomes (8)
Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission.
Measured: Weeks 4, 8, 12, 26
Percent Change From Baseline in Tender and Swollen Joint Counts
Change in number of tender joints and swollen joints for 28 assessed joints.
Measured: Weeks 4, 8, 12, 26
Percent Change From Baseline in C-reactive Protein
C-reactive protein level in serum (mg/dL)
Measured: Weeks 4, 8, 12, 26
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation.
Measured: Weeks 4, 8, 12, 26
Percent Change From Baseline in Patient's Global Assessment of Disease Activity
A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly).
Measured: Weeks 4, 8, 12, 26
Percent Change From Baseline in Patient's Assessment of Pain
A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be).
Measured: Weeks 4, 8, 12, 26
Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity
A horizontal VAS (100 mm) measure of the physician's global assessment of the participant's current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition).
Measured: Weeks 4, 8, 12, 26
Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).
Measured: Weeks 4, 8, 12, 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: This study was prematurely terminated due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ArthritisStudies of the same condition, open and under way.
- 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawn Carlson, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464021
- Sponsor's protocol ID
- P13-194
- Status last verified
- Feb 2014
- First submitted
- 31 Oct 2011
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
- ClinicalTrials.gov ID
- NCT01464021
- Acronym / sponsor ID
- P13-194
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Study, prospective, Rheumatoid, Observational study, Arthritis, Adalimumab
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was prematurely terminated due to low enrollment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Posted 30 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China.
Detailed description
This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered subcutaneously (SC). Adalimumab effectiveness will be assessed based on data from clinic visits beginning at Baseline and continuing per standard of care for RA. The primary objective is to evaluate the effectiveness of adalimumab in improving patients' disease activity measured by Disease Activity Score (DAS28) at Week 12. The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. The study was terminated due to low enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | – | –Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
Key inclusion criteria (4 listed)
- Male or female patient greater than or equal to 18 years of age with diagnosis of RA (Rheumatoid Arthritis) and no history of chronic arthritis before age 16.
- Patient meets the requirements for treatment with adalimumab per the local product label.
- Patient is naïve to adalimumab, and has not used any other immunomodulatory biologic* DMARD (Disease Modifying Antirheumatic Drugs) in the past 8 weeks before the Baseline visit (*rituximab may not have been used in the past 104 weeks before the Baseline visit).
- Patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by Abbott.
Key exclusion criteria (4 listed)
- Patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline visit.
- Prior clinically active TB (tuberculosis): if patient has had prior clinically active TB, there should be documentation that a full course of appropriate anti-TB therapy was completed or an ongoing full course of appropriate anti-TB therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study.
- Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab.
- Patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the Investigator determines that they should not be enrolled based on his/her clinical 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
Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response
Time frame: Week 12
A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1
8 secondary outcomes
Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)
Time frame: Weeks 4, 8, 12, 26
Percent Change From Baseline in Tender and Swollen Joint Counts
Time frame: Weeks 4, 8, 12, 26
Percent Change From Baseline in C-reactive Protein
Time frame: Weeks 4, 8, 12, 26
Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Weeks 4, 8, 12, 26
Percent Change From Baseline in Patient's Global Assessment of Disease Activity
Time frame: Weeks 4, 8, 12, 26
Percent Change From Baseline in Patient's Assessment of Pain
Time frame: Weeks 4, 8, 12, 26
Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity
Time frame: Weeks 4, 8, 12, 26
Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time frame: Weeks 4, 8, 12, 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Dawn Carlson study director
AbbVie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Rheumatoid, run by AbbVie (prior sponsor, Abbott) at 3 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 4 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: stopped early, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 30 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response (time frame: Week 12). 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 6 Mar 2014.