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The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy.
This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Run-In: Etanercept plus Methotrexate | Experimental | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care. |
|
| Double-Blind Treatment: Methotrexate Monotherapy | Experimental | Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
|
| Double-Blind Treatment: Etanercept Monotherapy | Experimental | Etanercept 50 mg weekly by subcutaneous injection plus placebo for methotrexate for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
|
| Double-Blind Treatment: Etanercept plus Methotrexate |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept pre-filled syringe subcutaneous injection | Drug | etanercept for injection in pre-filled syringes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
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Inclusion Criteria (Part 1, Run-In Period):
Exclusion Criteria (Part 1, Run-In Period):
Subject has used biologic disease modifying antirheumatic drug other than etanercept OR has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit 1
Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to run-in visit 1.
Subject has known alcohol addiction or dependency or uses alcohol daily.
Subject has one or more significant concurrent medical conditions per investigator judgment, including the following:
Inclusion Criteria (Part 2, Treatment Period):
Exclusion Criteria (Part 2, Treatment Period):
NOTE: Other inclusion/exclusion criteria may apply per protocol.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35205 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29224127 | Background | Curtis JR, Trivedi M, Haraoui B, Emery P, Park GS, Collier DH, Aras GA, Chung J. Defining and characterizing sustained remission in patients with rheumatoid arthritis. Clin Rheumatol. 2018 Apr;37(4):885-893. doi: 10.1007/s10067-017-3923-z. Epub 2017 Dec 9. | |
| 33205906 | Background | Curtis JR, Emery P, Karis E, Haraoui B, Bykerk V, Yen PK, Kricorian G, Chung JB. Etanercept or Methotrexate Withdrawal in Rheumatoid Arthritis Patients in Sustained Remission. Arthritis Rheumatol. 2021 May;73(5):759-768. doi: 10.1002/art.41589. Epub 2021 Mar 24. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
After a 24-week open label run-in period, participants were randomly assigned in a 2:2:1 ratio to one of three treatment groups: methotrexate monotherapy, etanercept monotherapy, or etanercept plus methotrexate.
This study was conducted at 97 centers in Canada, United States, Argentina, Bulgaria, Czech Republic, Spain, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, and South Africa. The first participant enrolled on 20 February 2015; the last participant enrolled on 26 June 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Run-In: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care. |
| FG001 | Double-Blind Treatment: Methotrexate Monotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-In Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 17, 2017 | Nov 24, 2020 |
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| Experimental |
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening will continue on the assigned treatments (as rescue treatment). |
|
|
| Oral methotrexate | Drug | During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets. During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules. |
|
| Placebo for etanercept subcutaneous injection | Drug | etanercept placebo for injection in pre-filled syringes |
|
| Placebo for methotrexate | Drug | methotrexate placebo capsules |
|
| Folic acid (non-investigational product) | Dietary Supplement | Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care. |
|
| Week 48 |
| SDAI Score at All Measured Timepoints | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in SDAI Score at All Measured Timepoints | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in DAS28-ESR at All Measured Timepoints | The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in DAS28-CRP at All Measured Timepoints | The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Clinical Disease Activity Index (CDAI) at All Measured Timepoints | The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Change From Baseline in CDAI at All Measured Timepoints | The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. A negative change from baseline indicates improvement. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Percentage of Participants With Boolean Remission at All Measured Timepoints | A participant achieves Boolean remission (66/68-joint count) if all of the following criteria are met at a single timepoint:
| Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Percentage of Participants With Disease Worsening | Percentage of participants who fulfilled disease-worsening criteria for the first time is presented. Disease worsening is defined as any of the following:
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Baseline, Week 12, Week 24, Week 36 and Week 48 |
| Time to Disease Worsening | Disease worsening is defined as any of the following:
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | up to Week 48 |
| Time to Recapture SDAI Remission After Starting Rescue Treatment | In participants who receive rescue treatment during the double-blind treatment period. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Between rescue and remission or Week 48, whichever comes first. |
| Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Week 48 |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Research Site | Huntsville | Alabama | 35801 | United States |
| Research Site | Glendale | Arizona | 85306 | United States |
| Research Site | Mesa | Arizona | 85202 | United States |
| Research Site | Phoenix | Arizona | 85037 | United States |
| Research Site | Scottsdale | Arizona | 85258 | United States |
| Research Site | Escondido | California | 92025 | United States |
| Research Site | Fontana | California | 92335 | United States |
| Research Site | Hemet | California | 92543 | United States |
| Research Site | Huntington Beach | California | 92646 | United States |
| Research Site | La Jolla | California | 92037 | United States |
| Research Site | Murrieta | California | 92563 | United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | Sacramento | California | 95817 | United States |
| Research Site | Santa Maria | California | 93454-6945 | United States |
| Research Site | Torrance | California | 90502 | United States |
| Research Site | Tustin | California | 92780 | United States |
| Research Site | Victorville | California | 92395 | United States |
| Research Site | West Hills | California | 91307 | United States |
| Research Site | Doral | Florida | 33126 | United States |
| Research Site | Fort Lauderdale | Florida | 33309 | United States |
| Research Site | Gainesville | Florida | 32607 | United States |
| Research Site | Miami | Florida | 33126 | United States |
| Research Site | Miami | Florida | 33144 | United States |
| Research Site | Orlando | Florida | 32806 | United States |
| Research Site | Palm Harbor | Florida | 34684 | United States |
| Research Site | Pensacola | Florida | 32514 | United States |
| Research Site | St. Petersburg | Florida | 33705 | United States |
| Research Site | Tampa | Florida | 33613 | United States |
| Research Site | Lawrenceville | Georgia | 30046 | United States |
| Research Site | Boise | Idaho | 83702 | United States |
| Research Site | Meridian | Idaho | 83642 | United States |
| Research Site | Blue Island | Illinois | 60406 | United States |
| Research Site | Skokie | Illinois | 60076 | United States |
| Research Site | Springfield | Illinois | 62703 | United States |
| Research Site | Granger | Indiana | 46530 | United States |
| Research Site | Baton Rouge | Louisiana | 70809 | United States |
| Research Site | New Orleans | Louisiana | 70121 | United States |
| Research Site | Wheaton | Maryland | 20902 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Detroit | Michigan | 48202 | United States |
| Research Site | Grand Rapids | Michigan | 49546 | United States |
| Research Site | Kalamazoo | Michigan | 49008 | United States |
| Research Site | Lansing | Michigan | 48910 | United States |
| Research Site | Lansing | Michigan | 48917 | United States |
| Research Site | Springfield | Missouri | 65807 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Clifton | New Jersey | 07012 | United States |
| Research Site | Freehold | New Jersey | 07728 | United States |
| Research Site | Newark | New Jersey | 07103 | United States |
| Research Site | Albuquerque | New Mexico | 87102 | United States |
| Research Site | Brooklyn | New York | 11201 | United States |
| Research Site | Great Neck | New York | 11021 | United States |
| Research Site | New York | New York | 10021 | United States |
| Research Site | Charlotte | North Carolina | 28204 | United States |
| Research Site | Greenville | North Carolina | 27834 | United States |
| Research Site | Oklahoma City | Oklahoma | 73103 | United States |
| Research Site | Duncansville | Pennsylvania | 16635 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15224 | United States |
| Research Site | Wynnewood | Pennsylvania | 19096 | United States |
| Research Site | Wyomissing | Pennsylvania | 19610 | United States |
| Research Site | Charleston | South Carolina | 29406 | United States |
| Research Site | Orangeburg | South Carolina | 29118 | United States |
| Research Site | Jackson | Tennessee | 38305 | United States |
| Research Site | Knoxville | Tennessee | 37909-1900 | United States |
| Research Site | Carrollton | Texas | 75007 | United States |
| Research Site | Corpus Christi | Texas | 78404 | United States |
| Research Site | Cypress | Texas | 77429 | United States |
| Research Site | League City | Texas | 77573 | United States |
| Research Site | Plano | Texas | 75024 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Webster | Texas | 77598 | United States |
| Research Site | Danville | Virginia | 24541 | United States |
| Research Site | Buenos Aires | 1425 | Argentina |
| Research Site | Plovdiv | 4000 | Bulgaria |
| Research Site | Plovdiv | 4002 | Bulgaria |
| Research Site | Sofia | 1505 | Bulgaria |
| Research Site | Sofia | 1612 | Bulgaria |
| Research Site | Sofia | 1784 | Bulgaria |
| Research Site | Winnipeg | Manitoba | R3N 0K6 | Canada |
| Research Site | Sydney | Nova Scotia | B1S 3N1 | Canada |
| Research Site | Hamilton | Ontario | L8N 1Y2 | Canada |
| Research Site | Montreal | Quebec | H2L 1S6 | Canada |
| Research Site | Québec | Quebec | G1V 3M7 | Canada |
| Research Site | Rimouski | Quebec | G5L 8W1 | Canada |
| Research Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Research Site | Prague | 128 50 | Czechia |
| Research Site | Uherské Hradiště | 686 01 | Czechia |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Cahors | 46005 | France |
| Research Site | Montpellier | 34295 | France |
| Research Site | Orléans | 45067 | France |
| Research Site | Paris | 75010 | France |
| Research Site | Berlin | 14059 | Germany |
| Research Site | Frankfurt am Main | 60590 | Germany |
| Research Site | Hildesheim | 31134 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Püttlingen | 66346 | Germany |
| Research Site | Athens | 11527 | Greece |
| Research Site | Athens | 12462 | Greece |
| Research Site | Athens | 14561 | Greece |
| Research Site | Heraklion | 71110 | Greece |
| Research Site | Thessaloniki | 54636 | Greece |
| Research Site | Thessaloniki | 56429 | Greece |
| Research Site | Budapest | 1023 | Hungary |
| Research Site | Budapest | 1036 | Hungary |
| Research Site | Veszprém | 8200 | Hungary |
| Research Site | Bari | 70124 | Italy |
| Research Site | Catania | 95124 | Italy |
| Research Site | Florence | 50139 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Reggio Emilia | 42123 | Italy |
| Research Site | Roma | 00128 | Italy |
| Research Site | Verona | 37126 | Italy |
| Research Site | Mexicali | Baja California Norte | 21100 | Mexico |
| Research Site | Guadalajara | Jalisco | 44650 | Mexico |
| Research Site | Monterrey | Nuevo León | 64020 | Mexico |
| Research Site | Chihuahua City | 31000 | Mexico |
| Research Site | Bydgoszcz | 85-168 | Poland |
| Research Site | Karwiany | 52-200 | Poland |
| Research Site | Sopot | 81-759 | Poland |
| Research Site | Stalowa Wola | 37-450 | Poland |
| Research Site | Coimbra | 3000-075 | Portugal |
| Research Site | Lisbon | 1050-034 | Portugal |
| Research Site | Lisbon | 1649-035 | Portugal |
| Research Site | Ponte de Lima | 4990-041 | Portugal |
| Research Site | Panorama | Western Cape | 7500 | South Africa |
| Research Site | Seville | Andalusia | 41009 | Spain |
| Research Site | Bilbao | Basque Country | 48013 | Spain |
| Research Site | Salamanca | Castille and León | 37007 | Spain |
| Research Site | Barcelona | Catalonia | 08026 | Spain |
| Research Site | A Coruña | Galicia | 15006 | Spain |
| Research Site | Majadahonda | Madrid | 28222 | Spain |
| Research Site | El Palmar | Murcia | 30120 | Spain |
| Research Site | Valencia | Valencia | 46017 | Spain |
| 36459119 | Background | Curtis JR, Stolshek B, Emery P, Haraoui B, Karis E, Kricorian G, Collier DH, Yen PK, Bykerk VP. Effects of Disease-Worsening Following Withdrawal of Etanercept or Methotrexate on Patient-Reported Outcomes in Patients With Rheumatoid Arthritis: Results From the SEAM-RA Trial. J Clin Rheumatol. 2023 Jan 1;29(1):16-22. doi: 10.1097/RHU.0000000000001893. Epub 2022 Oct 22. |
| 37061234 | Derived | Curtis JR, Emery P, Kricorian G, Yen PK, Collier DH, Bykerk V, Haraoui B. Factors Associated With Maintenance of Remission Following Change From Combination Therapy to Monotherapy in Patients With Rheumatoid Arthritis. J Rheumatol. 2023 Sep;50(9):1114-1120. doi: 10.3899/jrheum.2022-1008. Epub 2023 Apr 15. |
Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| FG002 | Double-Blind Treatment: Etanercept Monotherapy | Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| FG003 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
|
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| Double-Blind Treatment Period |
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Primary Analysis Set: All randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Treatment: Methotrexate Monotherapy | Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| BG001 | Double-Blind Treatment: Etanercept Monotherapy | Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| BG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Primary Analysis Set: all randomized participants. Nonresponder imputation. | Posted | Number | percentage of participants | Week 48 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Primary Analysis Set: all randomized participants. Nonresponder imputation. | Posted | Number | percentage of participants | Week 48 |
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| Secondary | SDAI Score at All Measured Timepoints | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. | Primary Analysis Set: all randomized participants. Observed cases at given timepoints. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Change From Baseline in SDAI Score at All Measured Timepoints | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. A negative change from baseline indicates improvement. | Primary Analysis Set: all randomized participants. Observed cases at given timepoint. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. | Primary Analysis Set: all randomized participants. Observed cases at given timepoint. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Change From Baseline in DAS28-ESR at All Measured Timepoints | The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. | Primary Analysis Set: all randomized participants. Observed cases at given time point. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. | Primary Analysis Set: all randomized participants. Observed cases at given time point. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Change From Baseline in DAS28-CRP at All Measured Timepoints | The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. | Primary Analysis Set: all randomized participants. Observed cases at given timepoint. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. | Primary Analysis Set: all randomized participants. Observed cases at given timepoint. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Change From Baseline in CDAI at All Measured Timepoints | The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. A negative change from baseline indicates improvement. | Primary Analysis Set: all randomized participants. Observed cases at given timepoint. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Primary Analysis Set: all randomized participants. Observed cases at given time point. | Posted | Number | percentage of participants | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Percentage of Participants With Boolean Remission at All Measured Timepoints | A participant achieves Boolean remission (66/68-joint count) if all of the following criteria are met at a single timepoint:
| Primary Analysis Set: all randomized participants. Observed cases at given timepoint. | Posted | Number | percentage of participants | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Percentage of Participants With Disease Worsening | Percentage of participants who fulfilled disease-worsening criteria for the first time is presented. Disease worsening is defined as any of the following:
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Primary Analysis Set: all randomized participants. Observed cases at given timepoint. | Posted | Number | percentage of participants | Baseline, Week 12, Week 24, Week 36 and Week 48 |
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| Secondary | Time to Disease Worsening | Disease worsening is defined as any of the following:
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Primary Analysis Set: all randomized participants. Participants with disease worsening. | Posted | Median | Full Range | weeks | up to Week 48 |
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| Secondary | Time to Recapture SDAI Remission After Starting Rescue Treatment | In participants who receive rescue treatment during the double-blind treatment period. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Rescue Analysis Set: randomized participants who met the definition of disease-worsening and received both at least 1 dose of active rescue therapy etanercept and at least 1 dose of active rescue therapy methotrexate. Participants who recaptured SDAI remission. Observed cases. | Posted | Median | Full Range | weeks | Between rescue and remission or Week 48, whichever comes first. |
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| Secondary | Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. | Rescue Analysis Set: randomized participants who met the definition of disease-worsening and received both at least 1 dose of active rescue therapy etanercept and at least 1 dose of active rescue therapy methotrexate. Observed cases. | Posted | Number | percentage of participants | Week 48 |
|
Open-Label Run-In period: from enrollment up to 24 weeks. Double-Blind Treatment period: from randomization up to 48 weeks plus 30 days.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Label Run-In: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 24 weeks. Participants also receive folic acid as standard of care. | 0 | 368 | 14 | 368 | 29 | 368 |
| EG001 | Double-Blind Treatment: Methotrexate Monotherapy | Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). | 0 | 100 | 3 | 100 | 21 | 100 |
| EG002 | Double-Blind Treatment: Etanercept Monotherapy | Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). | 0 | 99 | 3 | 99 | 12 | 99 |
| EG003 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). | 0 | 53 | 2 | 53 | 8 | 53 |
| EG004 | Open Label Rescue: Etanercept Plus Methotrexate | After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). | 0 | 103 | 4 | 103 | 9 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Aortic pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Duodenal perforation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Abscess of salivary gland | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Prostate cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2020 | Nov 24, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D008727 | Methotrexate |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black |
|
| White |
|
| Other, Not Specified |
|
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|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
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| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
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| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
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| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
| OG002 |
| Double-Blind Treatment: Etanercept Plus Methotrexate |
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). |
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
|
|
|
| OG002 | Double-Blind Treatment: Etanercept Plus Methotrexate | Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care. After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). |
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