Rheumatoid ArthritisNCT00484809
Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children
An observational study of Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active… Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Enbrel (Etanercept)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Feb 2006
- Phase
- Observational
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inclusion in this study will be as per the approved indications in the package insert.
- Patients with moderately to severely active RA.
- Children with JRA who have had an inadequate response to one or more DMARDs.
Who cannot join
- Known hypersensitivity to etanercept or any of its components.
- Known significant concurrent medical disease, including:
- Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
- Cancer or history of cancer
- Active infection
- Sepsis or risk of sepsis
Show all 10Show fewer
- Active tuberculosis or a past history of tuberculosis
- Pancytopenia
- Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
- Patients who are planning to undergo elective surgery during the study period.
About this study
Official title: A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).
This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Enbrel (Etanercept)
- Keywords
- rheumatoid arthritis, juvenile rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enbrel (Etanercept)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startMar 2004
- Study completionFeb 2006
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants
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
- NCT00484809
- Sponsor's protocol ID
- 0881A-101511
- Status last verified
- Dec 2007
- First submitted
- 8 Jun 2007
- Last updated
- 14 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).
- ClinicalTrials.gov ID
- NCT00484809
- Acronym / sponsor ID
- 0881A-101511
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, juvenile rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 11 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 postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Inclusion in this study will be as per the approved indications in the package insert.
- Patients with moderately to severely active RA.
- Children with JRA who have had an inadequate response to one or more DMARDs.
Key exclusion criteria (10 listed)
- Known hypersensitivity to etanercept or any of its components.
- Known significant concurrent medical disease, including:
- Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
- Patients who are planning to undergo elective surgery during the study period.
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 |
|---|---|---|
| Enbrel (Etanercept) | Drug | – |
Primary outcome
Not reported in the source record.
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 14 Dec 2007.
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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 10 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 14 Dec 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.
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.
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 14 Dec 2007.