Rheumatoid ArthritisPhase 4NCT01270035
Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
A Phase 4 study testing Adalimumab in people with Rheumatoid Arthritis, run by Keio University at 2 sites in Japan.
Trial summary
In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesJapan
- Study dates
- Jan 2011to Jan 2014
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months disease activity : DAS28 > 5.1
Who cannot join
- allergy to ADA present active infection including TB history of demyelinating disease, HBV infection and malignancy
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Not yet recruiting
Saitama Medical Center
Kawagoe, Saitama, 350-8550
Koichi Amano, amanokoi@saitama-med.ac.jp
- Recruiting
Keio University Hospital
Shinanomachi, Tokyo, 160-8582
Hideto Kameda, kamehide@z6.keio.jp
About this study
In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 < 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 < 2.6) at 30 weeks with this predifined treatment strategy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- 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
To increase the ADA dose from 40 mg eow to 80 mg eow
| Study group | Role | What they receive |
|---|---|---|
| ADA 80 mg eow + MTX | Experimental | Not described Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of achieving remission at week 30
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keio University
- Sponsor type
- University, hospital or other
- Collaborators
- Saitama Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270035
- Sponsor's protocol ID
- ADA80MTX
- Status last verified
- Dec 2010
- First submitted
- 4 Jan 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
- ClinicalTrials.gov ID
- NCT01270035
- Acronym / sponsor ID
- ADA80MTX
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Keio UniversityUniversity, hospital or other
- Collaborators
- Saitama Medical University
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (estimated)
- First posted
- 5 Jan 2011 (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.
In Japan, as well as in other countries, the dose of adalimumab (ADA) is limited to 40 mg every other week when used in combination with methotrexate (MTX) for patients with rheumatoid arthritis (RA). However, ADA 80 mg with MTX may be required for some RA patients, especially for those with high disease activity. Therefore, we tried to increase the ADA dose to 80 mg every other week with concomitant MTX, only if the disease activity did not decrease below moderate activity defined by DAS28 < 3.2. The primary endpoint was the rate of patients who achieved disease remission (DAS28 < 2.6) at 30 weeks with this predifined treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADA 80 mg eow + MTX | Experimental | Drug: Adalimumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with rheumatoid arthritis receiving MTX ≧ 6 mg/week for at least 3 months disease activity : DAS28 > 5.1
Key exclusion criteria (1 listed)
- allergy to ADA present active infection including TB history of demyelinating disease, HBV infection and malignancy
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 |
|---|---|---|
| AdalimumabTo increase the ADA dose from 40 mg eow to 80 mg eow | Drug | ADA 80 mg eow + MTX |
Primary outcome
The rate of achieving remission at week 30
Time frame: 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab in people with Rheumatoid Arthritis, run by Keio University at 2 sites in Japan.
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 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hideto Kameda, MD. PhD (+81-3-5843-6179, kamehide@z6.keio.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of achieving remission at week 30 (time frame: 30 weeks). 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 27 Jun 2011.