Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission
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| ClinicalTrials.gov Identifier: NCT02373813 |
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Recruitment Status :
Completed
First Posted : February 27, 2015
Results First Posted : December 19, 2020
Last Update Posted : January 11, 2023
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Rheumatoid Arthritis |
| Interventions |
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) |
| Enrollment | 371 |
| Recruitment Details | 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. |
| Pre-assignment Details | 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. |
| Arm/Group Title | Open Label Run-In: Etanercept Plus Methotrexate | Double-Blind Treatment: Methotrexate Monotherapy | Double-Blind Treatment: Etanercept Monotherapy | Double-Blind Treatment: Etanercept Plus Methotrexate |
|---|---|---|---|---|
 Arm/Group Description |
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. |
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). |
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). |
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). |
| Period Title: Run-In Period | ||||
| Started | 371 | 0 | 0 | 0 |
| Treated | 368 | 0 | 0 | 0 |
| Completed | 255 [1] | 0 | 0 | 0 |
| Not Completed | 116 | 0 | 0 | 0 |
| Reason Not Completed | ||||
| Other, Not Specified | 5 | 0 | 0 | 0 |
| Withdrawal by Subject | 16 | 0 | 0 | 0 |
| Decision by Sponsor | 11 | 0 | 0 | 0 |
| Protocol Violation | 75 | 0 | 0 | 0 |
| Lost to Follow-up | 2 | 0 | 0 | 0 |
| Adverse Event | 3 | 0 | 0 | 0 |
| Noncompliance | 1 | 0 | 0 | 0 |
| Ineligibility Determined | 3 | 0 | 0 | 0 |
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[1]
1 participant who completed the run-in period had no end of study case report form.
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| Period Title: Double-Blind Treatment Period | ||||
| Started [1] | 0 | 101 | 101 | 51 |
| Received Investigational Product (IP) | 0 | 101 | 100 | 51 |
| Received Rescue Treatment | 0 | 52 | 36 | 15 |
| Completed | 0 | 88 | 92 | 47 |
| Not Completed | 0 | 13 | 9 | 4 |
| Reason Not Completed | ||||
| Decision by Sponsor | 0 | 1 | 2 | 0 |
| Protocol Violation | 0 | 2 | 0 | 0 |
| Lost to Follow-up | 0 | 0 | 1 | 1 |
| Withdrawal by Subject | 0 | 10 | 6 | 3 |
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[1]
One participant who completed the run-in period was not randomized.
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| Arm/Group Title | Double-Blind Treatment: Methotrexate Monotherapy | Double-Blind Treatment: Etanercept Monotherapy | Double-Blind Treatment: Etanercept Plus Methotrexate | Total | |
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Arm/Group Description |
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). |
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). |
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). |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 101 | 101 | 51 | 253 | |
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Baseline Analysis Population Description |
Primary Analysis Set: All randomized participants
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 101 participants | 101 participants | 51 participants | 253 participants | |
| 56.2 (11.4) | 54.8 (12.8) | 55.9 (12.6) | 55.6 (12.2) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 101 participants | 101 participants | 51 participants | 253 participants | |
| Female |
76 75.2%
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77 76.2%
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40 78.4%
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193 76.3%
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| Male |
25 24.8%
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24 23.8%
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11 21.6%
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60 23.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 101 participants | 101 participants | 51 participants | 253 participants | |
| Hispanic or Latino |
13 12.9%
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19 18.8%
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8 15.7%
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40 15.8%
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| Not Hispanic or Latino |
88 87.1%
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82 81.2%
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43 84.3%
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213 84.2%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 101 participants | 101 participants | 51 participants | 253 participants | |
| American Indian or Alaska Native |
4 4.0%
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3 3.0%
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2 3.9%
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9 3.6%
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| Asian |
2 2.0%
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0 0.0%
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1 2.0%
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3 1.2%
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| Black |
3 3.0%
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7 6.9%
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5 9.8%
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15 5.9%
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| White |
92 91.1%
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86 85.1%
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42 82.4%
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220 87.0%
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| Other, Not Specified |
0 0.0%
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5 5.0%
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1 2.0%
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6 2.4%
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