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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00393471




Registration number
NCT00393471
Ethics application status
Date submitted
26/10/2006
Date registered
27/10/2006
Date last updated
13/12/2023

Titles & IDs
Public title
Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.
Scientific 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.
Secondary ID [1] 0 0
0881A1-308
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Active Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Inclusion:

- Generally healthy of at least 18 years of age with active rheumatoid arthritis.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:

- A history or presence of clinically important medical disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- St. Leonards
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Southport
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussels
Country [3] 0 0
Belgium
State/province [3] 0 0
Diepenbeek
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Liege
Country [7] 0 0
Czechia
State/province [7] 0 0
Ceska Lipa
Country [8] 0 0
Czechia
State/province [8] 0 0
Praha
Country [9] 0 0
Czechia
State/province [9] 0 0
Terezin
Country [10] 0 0
Czechia
State/province [10] 0 0
Zlin
Country [11] 0 0
Denmark
State/province [11] 0 0
Copenhagen
Country [12] 0 0
Denmark
State/province [12] 0 0
Herlev
Country [13] 0 0
Finland
State/province [13] 0 0
Kuopio
Country [14] 0 0
Finland
State/province [14] 0 0
Rauma
Country [15] 0 0
Finland
State/province [15] 0 0
Tampere
Country [16] 0 0
Finland
State/province [16] 0 0
Vantaa
Country [17] 0 0
France
State/province [17] 0 0
Bordeaux
Country [18] 0 0
France
State/province [18] 0 0
Brest Cedex
Country [19] 0 0
France
State/province [19] 0 0
Creteil
Country [20] 0 0
France
State/province [20] 0 0
Grenoble Cedex
Country [21] 0 0
France
State/province [21] 0 0
Le Kremlin Bicetre
Country [22] 0 0
France
State/province [22] 0 0
Montpellier Cedex
Country [23] 0 0
France
State/province [23] 0 0
Nice Cedex
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France
State/province [24] 0 0
Paris Cedex
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Rouen
Country [27] 0 0
France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
France
State/province [28] 0 0
Toulouse Cedex
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Erlangen
Country [31] 0 0
Germany
State/province [31] 0 0
Herne
Country [32] 0 0
Germany
State/province [32] 0 0
Koln
Country [33] 0 0
Germany
State/province [33] 0 0
Leipzig
Country [34] 0 0
Germany
State/province [34] 0 0
Munchen
Country [35] 0 0
Germany
State/province [35] 0 0
Plauen
Country [36] 0 0
Germany
State/province [36] 0 0
Vogelsang
Country [37] 0 0
Germany
State/province [37] 0 0
Wurzburg
Country [38] 0 0
Greece
State/province [38] 0 0
Athens
Country [39] 0 0
Greece
State/province [39] 0 0
Thessaloniki
Country [40] 0 0
Israel
State/province [40] 0 0
Jerusalem
Country [41] 0 0
Israel
State/province [41] 0 0
Petah-Tikva
Country [42] 0 0
Italy
State/province [42] 0 0
Ferrara
Country [43] 0 0
Italy
State/province [43] 0 0
Firenze
Country [44] 0 0
Italy
State/province [44] 0 0
Genova
Country [45] 0 0
Italy
State/province [45] 0 0
Milano
Country [46] 0 0
Italy
State/province [46] 0 0
Napoli
Country [47] 0 0
Italy
State/province [47] 0 0
Pavia
Country [48] 0 0
Italy
State/province [48] 0 0
Udine
Country [49] 0 0
Netherlands
State/province [49] 0 0
Alkmaar
Country [50] 0 0
Netherlands
State/province [50] 0 0
Arnhem
Country [51] 0 0
Netherlands
State/province [51] 0 0
Doetinchem
Country [52] 0 0
Netherlands
State/province [52] 0 0
Enschede
Country [53] 0 0
Netherlands
State/province [53] 0 0
Leeuwarden
Country [54] 0 0
Netherlands
State/province [54] 0 0
Maastricht
Country [55] 0 0
Netherlands
State/province [55] 0 0
Nijmegen
Country [56] 0 0
Netherlands
State/province [56] 0 0
Tilburg
Country [57] 0 0
Netherlands
State/province [57] 0 0
Venlo
Country [58] 0 0
Norway
State/province [58] 0 0
Drammen
Country [59] 0 0
Norway
State/province [59] 0 0
Oslo
Country [60] 0 0
Poland
State/province [60] 0 0
Elblag
Country [61] 0 0
Poland
State/province [61] 0 0
Kalisz
Country [62] 0 0
Poland
State/province [62] 0 0
Krakow
Country [63] 0 0
Poland
State/province [63] 0 0
Warszawa
Country [64] 0 0
Poland
State/province [64] 0 0
Wroclaw
Country [65] 0 0
Portugal
State/province [65] 0 0
Lisbon
Country [66] 0 0
Romania
State/province [66] 0 0
Bucuresti
Country [67] 0 0
Romania
State/province [67] 0 0
Cluj-Japoca
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
Spain
State/province [69] 0 0
Guadalajara
Country [70] 0 0
Spain
State/province [70] 0 0
Madrid
Country [71] 0 0
Spain
State/province [71] 0 0
Santander
Country [72] 0 0
Spain
State/province [72] 0 0
Santiago de Compostela
Country [73] 0 0
Sweden
State/province [73] 0 0
Jonkoping
Country [74] 0 0
Sweden
State/province [74] 0 0
Kalmar
Country [75] 0 0
Sweden
State/province [75] 0 0
Linkoping
Country [76] 0 0
Sweden
State/province [76] 0 0
Stockholm
Country [77] 0 0
Sweden
State/province [77] 0 0
Uppsala
Country [78] 0 0
United Kingdom
State/province [78] 0 0
London
Country [79] 0 0
United Kingdom
State/province [79] 0 0
North Yorkshire
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Wyeth is now a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.
Trial website
https://clinicaltrials.gov/study/NCT00393471
Trial related presentations / 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.
van 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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00393471