Arthritis, RheumatoidPhase 3NCT00443950
Study Evaluating the Efficacy and Safety of Etanercept in Chinese Subjects With Rheumatoid Arthritis
A Phase 3 study testing Etanercept in people with Arthritis, Rheumatoid, run by Wyeth is now a wholly owned subsidiary of Pfizer at 6 sites in China.
Trial summary
The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Etanercept
- How many people
- 150 participants
- Where
- 6 sitesChina
- Study dates
- Jun 2006to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be of Chinese ancestry and living in China.
- Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.
- Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.
Who cannot join
- Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Study site
Beijing, 100029
Study site
Beijing, 100044
Study site
Beijing, 100853
Study site
Guangzhou, 510275
Study site
Shanghai, 200001
Study site
Xi'an, 710032
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate
The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Etanercept
- Keywords
- Arthritis, Chinese
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
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 endpoint is ACR20 response at 12 weeks.
Secondary outcomes (9)
Physician global assessments
Morning stiffness in minutes
Pain visual analog scale(VAS)
Health assessment questionnaire(HAQ)
C-reactive protein (CRP) values, Subject global assessments
Number of tender and swollen joints
ACR20 (at visit other than week 12)
ACR50
ACR70 responses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startJun 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies 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
- 150 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
- NCT00443950
- Sponsor's protocol ID
- 0881A1-319
- Status last verified
- Dec 2007
- First submitted
- 5 Mar 2007
- Last updated
- 13 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Etanercept in Chinese Subjects With Active Rheumatoid Arthritis Receiving Methotrexate
- ClinicalTrials.gov ID
- NCT00443950
- Acronym / sponsor ID
- 0881A1-319
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Arthritis, Chinese
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 7 Mar 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.
The objective of this study is to compare in Chinese subjects with rheumatoid arthritis (RA) the efficacy and safety in this subject population of 50 mg once-weekly injections of etanercept versus placebo in subjects receiving methotrexate. This is a multi-center, double-blind, randomized, parallel and placebo-controlled outpatient study. Approximately 150 subjects will participate in this study for about 18 weeks including a screening period up to 4 weeks, 12-week treatment period, and a 2-week follow-up period at approximately 25 sites.
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 (3 listed)
- Must be of Chinese ancestry and living in China.
- Meets the American Rheumatism Association 1987 Revised Criteria for the Classification of RA.
- Have active RA at the time of study enrollment (before the start of the screening period,) as demonstrated by 5 swollen and 5 tender/painful joints.
Key exclusion criteria (1 listed)
- Previous receipt of etanercept; antibody to tumor necrosis factor (TNF) antibody (infliximab, adalimumab), anti-CD4 antibody or diphtheria IL-2 fusion protein (DAB IL-2).
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 endpoint is ACR20 response at 12 weeks.
9 secondary outcomes
Physician global assessments
Morning stiffness in minutes
Pain visual analog scale(VAS)
Health assessment questionnaire(HAQ)
C-reactive protein (CRP) values, Subject global assessments
Number of tender and swollen joints
ACR20 (at visit other than week 12)
ACR50
ACR70 responses
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 13 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
6 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 Arthritis, Rheumatoid, run by Wyeth is now a wholly owned subsidiary of Pfizer at 6 sites in China.
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 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 13 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 6 sites in China. 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 endpoint is ACR20 response at 12 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 13 Dec 2007.