Study Comparing Etanercept and Methotrexate vs. Methotrex... | NCT00195494

Study Comparing Etanercept and Methotrexate vs. Methotrex... | NCT00195494 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1a	Active Comparator	Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)	Drug: Etanercept Drug: Methotrexate
1b	Active Comparator	Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)	Drug: Etanercept Drug: Methotrexate Drug: Placebo
2a	Active Comparator	Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)	Drug: Etanercept Drug: Methotrexate Drug: Placebo
2b	Active Comparator	Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)	Drug: Methotrexate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Etanercept	Drug	Group 1a: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 & 2 Group 1b: Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 1 then Etanercept 50 mg SC injections weekly + Placebo weekly for Period 2 Group 2a: Oral Methotrexate weekly + Placebo for Period 1, then Etanercept 50 mg SC injections weekly + oral Methotrexate weekly for Period 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.	Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.	12 months
Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.	The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death	Safety report for entire trial where participants reported a serious adverse event that led to death.	12 and 24 months

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Denver	Colorado	80230	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28255449	Derived	Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.
27175292	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	Year 1 E+M / Year 2 E+M	Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.
FG001	Year 1 M / Year 2 E+M	Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.
FG002	Year 1 E+M / Year 2 E	Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
FG003	Year 1 M / Year 2 M	Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.
FG004	Year 1 M+Placebo	Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites. MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.
FG005	Year 1 E+M	Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection). MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Periods

Title

Milestones

Reasons Not Completed

Year 1

Type	Comment	Milestone Data
STARTED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004268 subjects FG005274 subjects
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG003

Year 2

Type	Comment	Milestone Data
STARTED		FG000111 subjectsA patient with Year 1 termination had taken drug briefly during Year 2 and thus counted in the data. FG00190 subjects FG002111 subjectsA patient with Year 1 termination had taken drug briefly during Year 2 and thus counted in the data. FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Year 1 M+Placebo	Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites. MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.
BG001	Year 1 E+M

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous	Year 1 Overall Number of Baseline Participants is 542

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.

Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.

The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.

Posted

Mar 2009

Number

participants

12 months

ID	Title	Description
OG000	Year 1 M	Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
OG001	Year 1 E+M	etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Year 1 E+M / Year 2 E+M	Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection). Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Angina unstable	Cardiac disorders		Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Blood and lymphatic	Blood and lymphatic system disorders		Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
U. S. Contact Center	Wyeth			clintrialresults@wyeth.com

Condition Browse Module

ID	Term
D001172	Arthritis, Rheumatoid

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Intervention Browse Module

ID	Term
D000068800	Etanercept
D008727	Methotrexate

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Type	Comment	Reasons
Adverse Event		FG0003 subjects FG0017 subjects FG0025 subjects FG0039 subjects FG0040 subjects FG0050 subjects
Lack of Efficacy		FG0000 subjects FG0011 subjects FG0027 subjects FG0037 subjects FG004
Compliance		FG0001 subjects FG0010 subjects FG0020 subjects FG0032 subjects FG004
Lost to Follow-up		FG0000 subjects FG0010 subjects FG0021 subjects FG0031 subjects FG004
Missed >4 consecutive doses		FG0001 subjects FG0011 subjects FG0021 subjects FG0030 subjects FG004
Protocol deviation		FG0000 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004
Physician Decision		FG0001 subjects FG0011 subjects FG0020 subjects FG0030 subjects FG004
Withdrawal by Subject		FG0001 subjects FG0015 subjects FG0024 subjects FG0033 subjects FG004
System toxicity		FG0000 subjects FG0010 subjects FG0020 subjects FG0031 subjects FG004

Sex: Female, Male

Year 1 participants collected from Arms M and E+M equal the stated overall participant population of 542. 411 of those participants were then entered into Year 2 Arms E+M/E+M, M/M+E, E+M/E, M/M. This measure provides the gender population for Year 1 only in order to accurately reflect the overall baseline population of 542.

Count of Participants

Participants

Title

Denominators