Rheumatoid ArthritisPhase 4DOTARNCT00783536
A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis
A Phase 4 study testing Etanercept + Methotrexate and DMARDS in people with Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the previous 6 months will be eligible for the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Etanercept + Methotrexate and DMARDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Jun 2010
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject age 18 years or older
- Diagnosis of RA
- Disease duration of ≥ 6 months and ≤ 2 years
- Active disease at the time of randomization
- Negative serum pregnancy test at screening if female of childbearing potential.
- Women of childbearing potential participating in the study must use a medically acceptable form of contraception.
Show all 26Show fewer
- Sexually active male must agree to use a medically accepted form of contraception during the study. If partner is using and acceptable form of contraception, this criteria is not applicable.
- Subject is capable of understanding and signing an informed consent form
- Subject is able and willing to self-inject study drug or have a designee who can do so
- Subject is able and willing to take oral medication 11. Subject is able to store injectable test article at 2° C to 8° C 12. Demonstrates a negative tuberculosis screening test determined by chest
- Exculsion Criteria:
- Subject has received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist
- Subject has received any of the following DMARDs: methotrexate, leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, azathioprine, D-penicillamine, cyclophosphamide within the 6 months of screening visit by the rheumatologist
- Subject has received any investigational drug within 3 months of screening visit by the rheumatologist
- Subject has received any biologic agent in the past
- Subject has received any live (attenuated) vaccines within 4 weeks of screening visit by the rheumatologist
- Subject has received intra-articular corticosteroid injection within 4 weeks of screening visit by the rheumatologist
- Subject has received bolus intramuscular/intravenous treatment with corticosteroids (>20 mg prednisone or equivalent) within 4 weeks of screening visit by the rheumatologist
- Subject is taking > 10 mg/day of prednisone or equivalent within 4 weeks of screening visit by the rheumatologist
- A history or active presence of any of the following items will prevent enrollment:
- Significant concurrent medical diseases including cancer or a history of cancer Renal disease (creatinine level > 175 ?mol/L) History of drug abuse or psychiatric disease that would interfere with the subject's ability to comply with the requirements of this protocol.
- History of alcohol abuse that would interfere with the subject's ability to comply with the requirements of this protocol.
- History of known liver cirrhosis, fibrosis, or fatty liver History of any viral hepatitis within 1 year of screening
- Active presence of the following will also prevent enrollment Subject has a significant active infection or any underlying diseases that could predispose subjects to infections according to the investigators criteria Demonstrates liver function abnormality through clinical significant hepatic enzymes results ( twice the upper limits of normal).
- Subject has leucopoenia (white blood cells < 3500 x 106/L) Subject has thrombocytopenia (platelets < 125 x 109/L) Subject has a hemoglobin level of < 85 g/L Subject is scheduled for elective major surgery within the first year of study participation Pregnant or lactating women. Positive TB by PPD and abnormal chest ray
- Subject has a history of confirmed blood dyscrasias12. Subject has any condition judged by the physician to cause this study to be detrimental to the subject.
Who cannot join
None listed.
About this study
Official title: An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis
This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the previous 6 months will be eligible for the study. Study subjects will be randomized into one of two treatments groups and receive either etanercept + methotrexate or standard non-biologic DMARD therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Etanercept + Methotrexate, DMARDS
- Keywords
- An randomized, open label, multicenter study to compare the ef
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etanercept + MethotrexateDrug
DMARDSDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | * Clinical and demographic information
* Clinical and Laboratory information Receives: Drug: Etanercept + Methotrexate |
| 2 | Active comparator | * Clinical and demographic information
* Clinical and Laboratory information Receives: Drug: DMARDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low disease activity
Measured: 6 months
Secondary outcomes (1)
Effect of the combination therapy on physical function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT00783536
- Sponsor's protocol ID
- 0881A1-102380
- Acronym
- DOTAR
- Status last verified
- Jun 2009
- First submitted
- 29 Oct 2008
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized, Open Label, Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate With DMARD Therapy in Subjects With Active Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00783536
- Acronym / sponsor ID
- DOTAR / 0881A1-102380
- Conditions
- Rheumatoid Arthritis
- Keywords
- An randomized, open label, multicenter study to compare the ef
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 31 Oct 2008 (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 is a randomized, open label, active-comparator, parallel design, outpatient, multicenter study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the previous 6 months will be eligible for the study. Study subjects will be randomized into one of two treatments groups and receive either etanercept + methotrexate or standard non-biologic DMARD therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Etanercept + Methotrexate* Clinical and demographic information * Clinical and Laboratory information |
| 2 | Active comparator | Drug: DMARDS* Clinical and demographic information * Clinical and Laboratory information |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male or female subject age 18 years or older
- Diagnosis of RA
- Disease duration of ≥ 6 months and ≤ 2 years
- Active disease at the time of randomization
- Negative serum pregnancy test at screening if female of childbearing potential.
Key exclusion criteria (0 listed)
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 + Methotrexate | Drug | 1 |
| DMARDS | Drug | 2 |
Primary outcome
Low disease activity
Time frame: 6 months
1 secondary outcome
Effect of the combination therapy on physical function
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
Related trials for Rheumatoid Arthritis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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?
A Phase 4 study testing Etanercept + Methotrexate and DMARDS in people with 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 26 inclusion and 0 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: withdrawn, as of the sponsor's last update on 9 May 2022. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Low disease activity (time frame: 6 months). 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 9 May 2022.