Rheumatoid ArthritisPhase 3NCT00235859
Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
A Phase 3 study testing adalimumab and methotrexate in people with Rheumatoid Arthritis, run by Abbott.
Trial summary
The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- adalimumab and methotrexate
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9 tender joints
- Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX
- Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit
- Age 18 years and older
Who cannot join
- Prior treatment with any TNF antagonist, including adalimumab
- History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.
- Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.
- Chest X-ray with calcified granuloma and/or pleural scarring
- Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours
- Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition
- Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation
- Female who is pregnant or breast-feeding.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab, methotrexate
- Keywords
- Rheumatoid Arthritis, adalimumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumabDrug
methotrexateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20
Secondary outcomes (1)
Safety parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Investigators
- Beverly Paperiello, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235859
- Sponsor's protocol ID
- M02-556
- Status last verified
- Aug 2007
- First submitted
- 7 Oct 2005
- Last updated
- 29 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PubMed 27338778
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate
- ClinicalTrials.gov ID
- NCT00235859
- Acronym / sponsor ID
- M02-556
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, adalimumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Study start
- Jul 2003
- First posted
- 12 Oct 2005 (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.
The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9 tender joints
- Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX
- Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit
- Age 18 years and older
Key exclusion criteria (8 listed)
- Prior treatment with any TNF antagonist, including adalimumab
- History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.
- Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.
- Chest X-ray with calcified granuloma and/or pleural scarring
- Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumab | Drug | – |
| methotrexate | Drug | – |
Primary outcome
ACR20
1 secondary outcome
Safety parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2007.
- Derived from this study: PubMed 27338778Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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.
Beverly Paperiello study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing adalimumab and methotrexate in people with Rheumatoid Arthritis, run by Abbott.
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 8 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 29 Aug 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ACR20. 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 NCT00235859, 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 29 Aug 2007.