Rheumatoid ArthritisPhase 3NCT00484237
A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis
A Phase 3 study testing etanercept in people with Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites in Japan.
Trial summary
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- etanercept
- How many people
- 80 participants
- Where
- 13 sitesJapan
- Study dates
- Apr 2007to Dec 2007
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of >6 swollen joints and >6 tender joints
- Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
- Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit
Who cannot join
- Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
- Received investigational drugs within 6 months of the baseline visit
- Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Study site
Choseigun, Chiba, 299-4301
Study site
Fukuoka, Fukuoka, 810-0001
Study site
Fukushima, Fukushima, 960-8251
Study site
Goshogawara, Aomori, 037-0053
Study site
Higashihiroshima, Hiroshima, 790-0002
Study site
Katoh, Hyōgo, 673-1462
Study site
Kumamoto, Kumamoto, 862-0976
Study site
Nagano, Nagano, 380-0928
Study site
Ōita, Oita Prefecture, 870-0823
Study site
Sagamihara, Kanagawa, 228-8522
Study site
Sasebo, Nagasaki, 857-1195
Study site
Sendai, Miyagi, 982-0032
Study site
Yotsukaidō, Chiba, 284-0003
About this study
Official title: A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Read the detailed description
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
- Conditions
- Rheumatoid Arthritis
- Being tested
- etanercept
- 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.
etanerceptDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
Secondary outcomes (1)
ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startApr 2007
- Study completionDec 2007
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484237
- Sponsor's protocol ID
- 0881A1-3324
- Status last verified
- Dec 2007
- First submitted
- 7 Jun 2007
- Last updated
- 5 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00484237
- Acronym / sponsor ID
- 0881A1-3324
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 8 Jun 2007 (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.
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Detailed description
This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of >6 swollen joints and >6 tender joints
- Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
- Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit
Key exclusion criteria (3 listed)
- Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
- Received investigational drugs within 6 months of the baseline visit
- Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit
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 |
|---|---|---|
| etanercept | Drug | – |
Primary outcome
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).
1 secondary outcome
ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.
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 5 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing etanercept in people with Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 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 3 inclusion and 3 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 5 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 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?
The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at 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 5 Dec 2007.