- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01783730
Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents
September 2, 2016 updated by: AbbVie
Special Investigation in Japanese Rheumatoid Arthritis Patients Who Have no Previous Use of DMARDs and Biological Agents
This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.
Study Overview
Status
Completed
Conditions
Detailed Description
This was a multicenter, prospective, observational study of adalimumab.
Each participant enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until discontinuation of the drug.
Study Type
Observational
Enrollment (Actual)
163
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Rheumatoid Arthritis participants showing rapid progression of structural damage of the joints, who have no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.
Description
Inclusion Criteria:
- High disease activity, with poor prognostic factors (e.g., rheumatoid factor [RF]-positive, anti-cyclic citrullinated peptide [CCP] antibody-positive, or bone erosion)
- Combination of adalimumab and methotrexate will be started
- No prior history of treatment with disease-modifying anti-rheumatic drugs
- No prior history of treatment with biological agents
- Adalimumab dosed according to the registered product label
- Signed informed consent
Exclusion Criteria:
There were no specific exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Participants with high rheumatoid arthritis disease activity
Participants who received adalimumab treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: From baseline through week 26
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.
|
From baseline through week 26
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline
Time Frame: at week 0
|
The DAS28-4(ESR) 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 were included in the DAS28 score.
Scores on the DAS28 range from 0 to 10.
A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
|
at week 0
|
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4
Time Frame: at week 4
|
The DAS28-4(ESR) 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 were included in the DAS28 score.
Scores on the DAS28 range from 0 to 10.
A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .
|
at week 4
|
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12
Time Frame: at week 12
|
The DAS28-4(ESR) 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 were included in the DAS28 score.
Scores on the DAS28 range from 0 to 10.
A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .
|
at week 12
|
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24
Time Frame: at week 24
|
The DAS28-4(ESR) 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 were included in the DAS28 score.
Scores on the DAS28 range from 0 to 10.
A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
|
at week 24
|
Percentage of Participants Achieving DAS28-4(ESR) Remission
Time Frame: From baseline to 24 weeks
|
The DAS28-4(ESR) 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 were included in the DAS28 score.
Scores on the DAS28 range from 0 to 10.
A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
The percentage of participants with a DAS28 score <2.6 was documented.
|
From baseline to 24 weeks
|
Mean Clinical Disease Activity Index (CDAI) Score at Baseline
Time Frame: at week 0
|
The CDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score.
Scores on the CDAI range from 0 to 76.
A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
|
at week 0
|
Mean Clinical Disease Activity Index (CDAI) Score at Week 4
Time Frame: at week 4
|
The CDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score.
Scores on the CDAI range from 0 to 76.
A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
|
at week 4
|
Mean Clinical Disease Activity Index (CDAI) Score at Week 12
Time Frame: at week 12
|
The CDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score.
Scores on the CDAI range from 0 to 76.
A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
|
at week 12
|
Mean Clinical Disease Activity Index (CDAI) Score at Week 24
Time Frame: at week 24
|
The CDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score.
Scores on the CDAI range from 0 to 76.
A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
|
at week 24
|
Percentage of Participants Achieving CDAI Remission
Time Frame: From baseline to 24 weeks
|
The CDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score.
Scores on the CDAI range from 0 to 76.
A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.
The percentage of participants with a CDAI score ≤2.8 was documented.
|
From baseline to 24 weeks
|
Mean Simplified Disease Activity Index (SDAI) Score at Baseline
Time Frame: at week 0
|
The SDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score.
Scores on the SDAI range from 0 to 86.
An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
|
at week 0
|
Mean Simplified Disease Activity Index (SDAI) Score at Week 4
Time Frame: at week 4
|
The SDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score.
Scores on the SDAI range from 0 to 86.
An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
|
at week 4
|
Mean Simplified Disease Activity Index (SDAI) Score at Week 12
Time Frame: at week 12
|
The SDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score.
Scores on the SDAI range from 0 to 86.
An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
|
at week 12
|
Mean Simplified Disease Activity Index (SDAI) Score at Week 24
Time Frame: at week 24
|
The SDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score.
Scores on the SDAI range from 0 to 86.
An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
|
at week 24
|
Percentage of Participants Achieving SDAI Remission
Time Frame: From baseline to 24 weeks
|
The SDAI is a validated measure of rheumatoid arthritis disease activity.
Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score.
Scores on the SDAI range from 0 to 86.
An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.
The percentage of participants with an SDAI score ≤3.3 was documented.
|
From baseline to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sarina Kurimoto, MD, AbbVie GK.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
February 1, 2013
First Submitted That Met QC Criteria
February 1, 2013
First Posted (Estimate)
February 5, 2013
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
September 2, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P13-983
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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