Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission

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ClinicalTrials.gov Identifier: NCT02373813

Recruitment Status : Completed

First Posted : February 27, 2015

Results First Posted : December 19, 2020

Last Update Posted : January 11, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Amgen

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: etanercept pre-filled syringe subcutaneous injection Drug: Oral methotrexate Drug: Placebo for etanercept subcutaneous injection Drug: Placebo for methotrexate Dietary Supplement: Folic acid (non-investigational product)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	371 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized Withdrawal Double-blind Study of Etanercept Monotherapy Compared to Methotrexate Monotherapy for Maintenance of Remission in Subjects With Rheumatoid Arthritis
Actual Study Start Date :	February 20, 2015
Actual Primary Completion Date :	December 6, 2019
Actual Study Completion Date :	December 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: etanercept pre-filled syringe subcutaneous injection etanercept for injection in pre-filled syringes Other Names: Enbrel AMG916 Drug: Oral methotrexate 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. Dietary Supplement: Folic acid (non-investigational product) Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.
Experimental: 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 will initiate rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg).	Drug: etanercept pre-filled syringe subcutaneous injection etanercept for injection in pre-filled syringes Other Names: Enbrel AMG916 Drug: Oral methotrexate 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. Drug: Placebo for etanercept subcutaneous injection etanercept placebo for injection in pre-filled syringes Dietary Supplement: Folic acid (non-investigational product) Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.
Experimental: Double-Blind Treatment: Etanercept Monotherapy 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).	Drug: etanercept pre-filled syringe subcutaneous injection etanercept for injection in pre-filled syringes Other Names: Enbrel AMG916 Drug: Oral methotrexate 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. Drug: Placebo for methotrexate methotrexate placebo capsules Dietary Supplement: Folic acid (non-investigational product) Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.
Experimental: 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 will continue on the assigned treatments (as rescue treatment).	Drug: etanercept pre-filled syringe subcutaneous injection etanercept for injection in pre-filled syringes Other Names: Enbrel AMG916 Drug: Oral methotrexate 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. Dietary Supplement: Folic acid (non-investigational product) Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.

Outcome Measures

Primary Outcome Measures :

Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy [ Time Frame: 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.

Secondary Outcome Measures :

Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy [ Time Frame: 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.
SDAI Score at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and 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.
Change From Baseline in SDAI Score at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and 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. A negative change from baseline indicates improvement.
Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
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.
Change From Baseline in DAS28-ESR at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
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.
Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
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.
Change From Baseline in DAS28-CRP at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
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.
Clinical Disease Activity Index (CDAI) at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
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.
Change From Baseline in CDAI at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
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.
Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and 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.
Percentage of Participants With Boolean Remission at All Measured Timepoints [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
A participant achieves Boolean remission (66/68-joint count) if all of the following criteria are met at a single timepoint:
- 68-joint tender joint count ≤ 1
- 66-joint swollen joint count ≤ 1
- CRP (mg/dL) ≤ 1
- Patient's Global Assessment of Disease Activity using a VAS (where 0=no arthritis activity at all and 10=worst arthritis activity imaginable) ≤ 1.
Percentage of Participants With Disease Worsening [ Time Frame: Baseline, Week 12, Week 24, Week 36 and Week 48 ]
Percentage of participants who fulfilled disease-worsening criteria for the first time is presented. Disease worsening is defined as any of the following:
- an SDAI > 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart
- SDAI > 3.3 and ≤ 11 on 3 or more separate visits
- SDAI > 11 after randomization.
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.
Time to Disease Worsening [ Time Frame: up to Week 48 ]
Disease worsening is defined as any of the following:
- an SDAI > 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart
- SDAI > 3.3 and ≤ 11 on 3 or more separate visits
- SDAI > 11 after randomization.
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.
Time to Recapture SDAI Remission After Starting Rescue Treatment [ Time Frame: Between rescue and remission or Week 48, whichever comes first. ]
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.
Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria (Part 1, Run-In Period):

Subjects must be adults with a history of moderate to severe rheumatoid arthritis;
Subjects must be in very good rheumatoid arthritis disease control for ≥ 6 months and be in remission as defined by a Simplified Disease Activity Index ≤ 3.3 at screening and at the end of the run-in period.
Subjects must be on etanercept 50 mg per week plus methotrexate therapy for ≥ 6 months prior to the start of the run-in period. The methotrexate dose must be 10 to 25 mg per week for ≥ 6 months prior to the start of the run-in period and the dose must be stable for ≥ 8 weeks prior to the start of the run-in period.
Subject has no known history of active tuberculosis, and has a negative test for tuberculosis during screening.

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:
- poorly controlled diabetes
- chronic kidney disease stage IIIb, IV, or V
- symptomatic heart failure (New York Heart Association class II, III, or IV)
- myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
- uncontrolled hypertension
- severe chronic pulmonary disease (eg, requiring oxygen therapy)
- multiple sclerosis or any other demyelinating disease
- major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus with the exception of secondary Sjögren's syndrome)

Inclusion Criteria (Part 2, Treatment Period):

SDAI ≤ 3.3 at run-in visit 3
Subject if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative urine pregnancy test at baseline (day 1).

Exclusion Criteria (Part 2, Treatment Period):

Any clinically significant change in the Part 1 eligibility criteria during the run-in period
SDAI > 3.3 and ≤ 11 on two consecutive visits at least two weeks apart OR SDAI > 3.3 and ≤ 11 on two or more separate visits OR SDAI > 11 at any time during the run-in period
Subject has a clinically significant laboratory abnormality during run-in period which in the opinion of the investigator poses a safety risk, will prevent the subject from completing the study, or will interfere with the interpretation of the study results during the run-in period.

NOTE: Other inclusion/exclusion criteria may apply per protocol.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373813

Locations

Show 136 study locations

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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35205
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Birmingham, Alabama, United States, 35294
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Huntsville, Alabama, United States, 35801
United States, Arizona
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Glendale, Arizona, United States, 85306
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Mesa, Arizona, United States, 85202
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Phoenix, Arizona, United States, 85037
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Scottsdale, Arizona, United States, 85258
United States, California
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Escondido, California, United States, 92025
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Fontana, California, United States, 92335
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Hemet, California, United States, 92543
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Huntington Beach, California, United States, 92646
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La Jolla, California, United States, 92037
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Murrieta, California, United States, 92563
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Orange, California, United States, 92868
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Sacramento, California, United States, 95817
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Santa Maria, California, United States, 93454-6945
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Torrance, California, United States, 90502
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Tustin, California, United States, 92780
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Victorville, California, United States, 92395
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West Hills, California, United States, 91307
United States, Florida
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Doral, Florida, United States, 33126
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Fort Lauderdale, Florida, United States, 33309
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Gainesville, Florida, United States, 32607
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33144
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Orlando, Florida, United States, 32806
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Palm Harbor, Florida, United States, 34684
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Pensacola, Florida, United States, 32514
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Saint Petersburg, Florida, United States, 33705
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Tampa, Florida, United States, 33613
United States, Georgia
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Lawrenceville, Georgia, United States, 30046
United States, Idaho
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Boise, Idaho, United States, 83702
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Meridian, Idaho, United States, 83642
United States, Illinois
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Blue Island, Illinois, United States, 60406
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Skokie, Illinois, United States, 60076
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Springfield, Illinois, United States, 62703
United States, Indiana
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Granger, Indiana, United States, 46530
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70809
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New Orleans, Louisiana, United States, 70121
United States, Maryland
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Wheaton, Maryland, United States, 20902
United States, Michigan
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Ann Arbor, Michigan, United States, 48109
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Detroit, Michigan, United States, 48202
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Grand Rapids, Michigan, United States, 49546
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Kalamazoo, Michigan, United States, 49008
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Lansing, Michigan, United States, 48910
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Lansing, Michigan, United States, 48917
United States, Missouri
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Saint Louis, Missouri, United States, 63141
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Springfield, Missouri, United States, 65807
United States, New Jersey
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Clifton, New Jersey, United States, 07012
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Freehold, New Jersey, United States, 07728
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Newark, New Jersey, United States, 07103
United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
United States, New York
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Brooklyn, New York, United States, 11201
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Great Neck, New York, United States, 11021
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New York, New York, United States, 10021
United States, North Carolina
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Charlotte, North Carolina, United States, 28204
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Greenville, North Carolina, United States, 27834
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
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Pittsburgh, Pennsylvania, United States, 15224
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Wynnewood, Pennsylvania, United States, 19096
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Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
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Charleston, South Carolina, United States, 29406
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Orangeburg, South Carolina, United States, 29118
United States, Tennessee
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Jackson, Tennessee, United States, 38305
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Knoxville, Tennessee, United States, 37909-1900
United States, Texas
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Carrollton, Texas, United States, 75007
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Corpus Christi, Texas, United States, 78404
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Cypress, Texas, United States, 77429
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League City, Texas, United States, 77573
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Plano, Texas, United States, 75024
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San Antonio, Texas, United States, 78229
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Webster, Texas, United States, 77598
United States, Virginia
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Danville, Virginia, United States, 24541
Argentina
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Buenos Aires, Argentina, 1425
Bulgaria
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Plovdiv, Bulgaria, 4000
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Plovdiv, Bulgaria, 4002
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Sofia, Bulgaria, 1505
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Sofia, Bulgaria, 1612
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Sofia, Bulgaria, 1784
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3N 0K6
Canada, Nova Scotia
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Sydney, Nova Scotia, Canada, B1S 3N1
Canada, Ontario
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Hamilton, Ontario, Canada, L8N 1Y2
Canada, Quebec
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Montreal, Quebec, Canada, H2L 1S6
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Rimouski, Quebec, Canada, G5L 8W1
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada
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Quebec, Canada, G1V 3M7
Czechia
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Praha 2, Czechia, 128 50
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Uherske Hradiste, Czechia, 686 01
France
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Bordeaux Cedex, France, 33076
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Cahors Cedex, France, 46005
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Montpellier cedex 05, France, 34295
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Orleans cedex 2, France, 45067
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Paris, France, 75010
Germany
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Berlin, Germany, 14059
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Frankfurt am Main, Germany, 60590
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Hildesheim, Germany, 31134
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Leipzig, Germany, 04103
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Püttlingen, Germany, 66346
Greece
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Athens, Greece, 11527
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Athens, Greece, 12462
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Athens, Greece, 14561
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Heraklion, Greece, 71110
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Thessaloniki, Greece, 54636
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Thessaloniki, Greece, 56429
Hungary
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Budapest, Hungary, 1023
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Budapest, Hungary, 1036
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Veszprem, Hungary, 8200
Italy
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Bari, Italy, 70124
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Catania, Italy, 95124
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Firenze, Italy, 50139
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Napoli, Italy, 80131
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Reggio Emilia, Italy, 42123
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Roma, Italy, 00128
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Verona, Italy, 37126
Mexico
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Mexicali, Baja California Norte, Mexico, 21100
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Guadalajara, Jalisco, Mexico, 44650
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Monterrey, Nuevo León, Mexico, 64020
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Chihuahua, Mexico, 31000
Poland
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Bydgoszcz, Poland, 85-168
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Karwiany, Poland, 52-200
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Sopot, Poland, 81-759
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Stalowa Wola, Poland, 37-450
Portugal
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Coimbra, Portugal, 3000-075
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Lisboa, Portugal, 1050-034
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Lisboa, Portugal, 1649-035
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Ponte de Lima, Portugal, 4990-041
South Africa
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Panorama, Western Cape, South Africa, 7500
Spain
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Sevilla, Andalucía, Spain, 41009
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Salamanca, Castilla León, Spain, 37007
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Barcelona, Cataluña, Spain, 08026
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Valencia, Comunidad Valenciana, Spain, 46017
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A Coruña, Galicia, Spain, 15006
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Majadahonda, Madrid, Spain, 28222
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El Palmar, Murcia, Spain, 30120
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Bilbao, País Vasco, Spain, 48013

Sponsors and Collaborators

Amgen

Investigators

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Study Director:	MD	Amgen

Study Documents (Full-Text)

Documents provided by Amgen:

Study Protocol [PDF] October 17, 2017

Statistical Analysis Plan [PDF] January 7, 2020

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT02373813
Other Study ID Numbers:	20110186
First Posted:	February 27, 2015 Key Record Dates
Results First Posted:	December 19, 2020
Last Update Posted:	January 11, 2023
Last Verified:	January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
Time Frame:	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
Access Criteria:	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.
URL:	https://www.amgen.com/datasharing

Additional relevant MeSH terms:

Layout table for MeSH terms

Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Folic Acid Etanercept Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs	Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents

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