Rheumatoid ArthritisNCT01783730
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
An observational study of Rheumatoid Arthritis, run by AbbVie.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 99 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Sep 2015
- 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 15 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- There were no specific exclusion criteria.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis
- 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 high rheumatoid arthritis disease activity | Participants who received adalimumab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
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.
Measured: From baseline through week 26
Secondary outcomes (15)
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline
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.
Measured: at week 0
Mean Disease Activity Score 28 (DAS28-4(ESR)) 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 .
Measured: at week 4
Mean Disease Activity Score 28 (DAS28-4(ESR)) 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 .
Measured: at week 12
Mean Disease Activity Score 28 (DAS28-4(ESR)) 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.
Measured: at week 24
Percentage of Participants Achieving DAS28-4(ESR) Remission
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.
Measured: From baseline to 24 weeks
Mean Clinical Disease Activity Index (CDAI) Score at Baseline
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.
Measured: at week 0
Mean Clinical Disease Activity Index (CDAI) Score 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.
Measured: at week 4
Mean Clinical Disease Activity Index (CDAI) Score 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.
Measured: at week 12
Mean Clinical Disease Activity Index (CDAI) Score 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.
Measured: at week 24
Percentage of Participants Achieving CDAI Remission
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.
Measured: From baseline to 24 weeks
Mean Simplified Disease Activity Index (SDAI) Score at Baseline
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.
Measured: at week 0
Mean Simplified Disease Activity Index (SDAI) Score 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.
Measured: at week 4
Mean Simplified Disease Activity Index (SDAI) Score 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.
Measured: at week 12
Mean Simplified Disease Activity Index (SDAI) Score 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.
Measured: at week 24
Percentage of Participants Achieving SDAI Remission
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.
Measured: From baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2015
- Study completionSep 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarina Kurimoto, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783730
- Sponsor's protocol ID
- P13-983
- Status last verified
- Sep 2016
- First submitted
- 1 Feb 2013
- Last updated
- 26 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ito Y, Hozumi K, Okada Y, Kurimoto S. Adalimumab with Methotrexate in Treatment-Naive Japanese Patients with Rheumatoid Arthritis at Risk of Progressive Structural Joint Damage: A Postmarketing Observational Study. Rheumatol Ther. 2017 Jun;4(1):151-166. doi: 10.1007/s40744-017-0059-1. Epub 2017 Mar 31.
PubMed 28364381
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Investigation in Japanese Rheumatoid Arthritis Patients Who Have no Previous Use of DMARDs and Biological Agents
- ClinicalTrials.gov ID
- NCT01783730
- Acronym / sponsor ID
- P13-983
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 26 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with high rheumatoid arthritis disease activity | – | –Participants who received adalimumab treatment |
Who may qualify
- Ages
- 15 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- There were no specific exclusion criteria.
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 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.
15 secondary outcomes
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline
Time frame: at week 0
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4
Time frame: at week 4
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12
Time frame: at week 12
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24
Time frame: at week 24
Percentage of Participants Achieving DAS28-4(ESR) Remission
Time frame: From baseline to 24 weeks
Mean Clinical Disease Activity Index (CDAI) Score at Baseline
Time frame: at week 0
Mean Clinical Disease Activity Index (CDAI) Score at Week 4
Time frame: at week 4
Mean Clinical Disease Activity Index (CDAI) Score at Week 12
Time frame: at week 12
Mean Clinical Disease Activity Index (CDAI) Score at Week 24
Time frame: at week 24
Percentage of Participants Achieving CDAI Remission
Time frame: From baseline to 24 weeks
Mean Simplified Disease Activity Index (SDAI) Score at Baseline
Time frame: at week 0
Mean Simplified Disease Activity Index (SDAI) Score at Week 4
Time frame: at week 4
Mean Simplified Disease Activity Index (SDAI) Score at Week 12
Time frame: at week 12
Mean Simplified Disease Activity Index (SDAI) Score at Week 24
Time frame: at week 24
Percentage of Participants Achieving SDAI Remission
Time frame: From baseline to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28364381Ito Y, Hozumi K, Okada Y, Kurimoto S. Adalimumab with Methotrexate in Treatment-Naive Japanese Patients with Rheumatoid Arthritis at Risk of Progressive Structural Joint Damage: A Postmarketing Observational Study. Rheumatol Ther. 2017 Jun;4(1):151-166. doi: 10.1007/s40744-017-0059-1. Epub 2017 Mar 31.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sarina Kurimoto, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by AbbVie.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 26 Oct 2016). 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 Adverse Events (time frame: From baseline through week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01783730, which also lists 1 linked publication.
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 Oct 2016.