Active Rheumatoid ArthritisPhase 3NCT00393471
Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.
A Phase 3 study testing Etanercept in people with Active Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 88 sites in 19 countries.
Trial summary
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- Etanercept
- How many people
- 615 participants
- Where
- 88 sitesin 19 countries
- Study dates
- Oct 2000to Oct 2001
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generally healthy of at least 18 years of age with active rheumatoid arthritis.
Who cannot join
- A history or presence of clinically important medical disease.
Trial locations and contacts
88 sites in 19 countries.
88 sites in 19 countries
France13 sites
Study site
Bordeaux, 33076
Study site
Brest, 29609
Study site
Créteil, 94010
Study site
Grenoble, 38043
Study site
Le Kremlin-Bicêtre, 94270
Study site
Montpellier, 34295
Study site
Nice, 06202
Study site
Paris, 75013
Study site
Paris, 75018
Study site
Paris, 75475
Study site
Rouen, 76031
Study site
Strasbourg, 67098
Study site
Toulouse, 31403
Germany9 sites
Study site
Berlin, 10117
Study site
Cologne, 50931
Study site
Erlangen, 91054
Study site
Herne, 44652
Study site
Leipzig, 04103
Study site
München, 80336
Study site
Plauen, 08525
Study site
Vogelsang, 39245
Study site
Würzburg, 97070
Netherlands9 sites
Study site
Alkmaar, 1815
Study site
Arnhem, 6815
Study site
Doetinchem, 7009
Study site
Enschede, 7513
Study site
Leeuwarden, 8934
Study site
Maastricht, 6229
Study site
Nijmegen, 6522
Study site
Tilburg, 5042
Study site
Venlo, 5912
Italy8 sites
Study site
Ferrara, 44100
Study site
Florence, 50413
Study site
Genova, 16132
Study site
Milan, 20122
Study site
Milan, 20162
Study site
Naples, 80100
Study site
Pavia, 27100
Study site
Udine, 33100
Spain7 sites
Study site
Barcelona, 08036
Study site
Guadalajara, 19002
Study site
Madrid, 28006
Study site
Madrid, 28040
Study site
Madrid, 28046
Study site
Santander, 39008
Study site
Santiago de Compostela, 15706
Belgium5 sites
Study site
Brussels, 5390
Study site
Diepenbeek, 3590
Study site
Ghent, 9000
Study site
Leuven, 3000
Study site
Liège, 4000
Poland5 sites
Study site
Elblag, 82-300
Study site
Kalisz, 62-800
Study site
Krakow, 30-119
Study site
Warsaw, 02-637
Study site
Wroclaw, 53-137
Sweden5 sites
Study site
Jönköping, 55185
Study site
Kalmar, 39185
Study site
Linköping, 58185
Study site
Stockholm, 17176
Study site
Uppsala, 75185
Czechia4 sites
Study site
Česká Lípa, 470 01
Study site
Prague, 128 500
Study site
Terezín, 411 55
Study site
Zlín, 760 01
Finland4 sites
Study site
Kuopio, 70100
Study site
Rauma, 26100
Study site
Tampere, 3311
Study site
Vantaa, 01400
Australia3 sites
Study site
Adelaide, 5000
Study site
Southport, 4215
Study site
St Leonards, New South Wales, 2065
United Kingdom3 sites
Study site
London, E11 1NR
Study site
North Yorks, HG2 7SX
Study site
Trent, ST6 7AG
About this study
Official title: A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.
Read the detailed description
Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- Etanercept
- Keywords
- Arthritis, Rheumatoid, Safety
- Medical subject headings
- 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 objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2006 (estimated)
- Study startOct 2000
- Study completionOct 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Active 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
- 615 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 PfizerTrial Manager, Principal investigator, For Australia, medinfo@wyeth.comTrial Manager, Principal investigator, For Austria, WPVIMED@wyeth.comTrial Manager, Principal investigator, For Belgium, trials-BEL@wyeth.comTrial Manager, Principal investigator, For Czech Republic, WPPGCLI@wyeth.comTrial Manager, Principal investigator, For Denmark, Finland, Norway, and Sweden, medinfonord@wyeth.comTrial Manager, Principal investigator, For France, infomedfrance@wyeth.comTrial Manager, Principal investigator, For Germany, medinfoDEU@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393471
- Sponsor's protocol ID
- 0881A1-308
- Status last verified
- Oct 2006
- First submitted
- 26 Oct 2006
- Last updated
- 13 Dec 2023
- Results posted
- No
Publications
Gallo G, Brock F, Kerkmann U, Kola B, Huizinga TW. Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage. RMD Open. 2016 Apr 21;2(1):e000186. doi: 10.1136/rmdopen-2015-000186. eCollection 2016.
PubMed 27175292van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, Herrero-Beaumont G, Molad Y, Codreanu C, Valentini G, Zahora R, Pedersen R, MacPeek D, Wajdula J, Fatenejad S. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007 Dec;56(12):3928-39. doi: 10.1002/art.23141.
PubMed 18050208
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.
- ClinicalTrials.gov ID
- NCT00393471
- Acronym / sponsor ID
- 0881A1-308
- Conditions
- Active Rheumatoid Arthritis
- Keywords
- Arthritis, Rheumatoid, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Study completion
- Oct 2001
- First posted
- 27 Oct 2006 (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.
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.
Detailed description
Etanercept is an injection administered under the skin twice weekly. Methotrexate is a tablet to be taken once weekly. Patients will not know which treatment they are on. Patients will need to meet the study criteria to be enrolled in the study and sign an informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy of at least 18 years of age with active rheumatoid arthritis.
Key exclusion criteria (1 listed)
- A history or presence of clinically important medical disease.
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 objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
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 2023.
- Derived from this study: PubMed 27175292Gallo G, Brock F, Kerkmann U, Kola B, Huizinga TW. Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage. RMD Open. 2016 Apr 21;2(1):e000186. doi: 10.1136/rmdopen-2015-000186. eCollection 2016.
- Derived from this study: PubMed 18050208van der Heijde D, Klareskog L, Landewe R, Bruyn GA, Cantagrel A, Durez P, Herrero-Beaumont G, Molad Y, Codreanu C, Valentini G, Zahora R, Pedersen R, MacPeek D, Wajdula J, Fatenejad S. Disease remission and sustained halting of radiographic progression with combination etanercept and methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2007 Dec;56(12):3928-39. doi: 10.1002/art.23141.
Related trials for Active Rheumatoid Arthritis
Not yet recruitingPhase 2
Platform Study of Targeted Therapies for Adults With Moderately to Severely Active Rheumatoid Arthritis
Rheumatoid Arthritis
Active, not recruitingObservational study
Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)
Active Rheumatoid Arthritis
Not yet recruiting
Acceptability of a Nurse-led Telehealth Remote Self-monitoring Model of Care in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis (RA)
RecruitingPhase 1
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)
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
Trial Manager principal investigator
For Australia, medinfo@wyeth.com
Trial Manager principal investigator
For Austria, WPVIMED@wyeth.com
88 sites in 19 countries: 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 Active Rheumatoid Arthritis, run by Wyeth is now a wholly owned subsidiary of Pfizer at 88 sites in 19 countries.
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: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in France, Germany, Netherlands, Italy, Spain and 14 more countries. 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 objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393471, which also lists 2 linked publications.
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 2023.