Phase 4
N=489
Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01578850 ↗Enrolled (actual)
489
Serious AEs
2.4%
Results posted
Jul 2016
Primary outcome: Primary: Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52. — 43.6; 17.3 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Etanercept (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52. |
43.6; 17.3 | <0.001 sig |
| SECONDARY Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR) |
53.2; 29.5 | 0.019 sig |
| SECONDARY Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1 |
9.5; 20.6; 20.3; 34.6; 32.8; 52.8 | — |
| SECONDARY Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2 |
0.0; 0.6; 0.6; 0.0; 100.0; 100.0 | 0.371 |
| SECONDARY Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1 |
4.0; 9.0; 8.9; 17.8; 13.5; 31.1 | — |
| SECONDARY Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2 |
0.0; 0.0; 0.0; 0.0; 38.0; 36.3 | 0.774 |
| SECONDARY Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1 |
-1.61; -1.61; -2.14; -2.09; -2.62; -2.54 | — |
| SECONDARY Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2 |
-3.79; -3.70; -3.36; -3.32; -3.35; -2.73 | <0.001 sig |
| SECONDARY Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria |
52.1; 79.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1. |
9.5; 18.9; 19.5; 33.5; 32.3; 51.9 | — |
| SECONDARY Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2. |
99.4; 99.4; 86.5; 85.1; 62.6; 41.1 | 0.961 |
| SECONDARY Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1. |
0.4; 16.7; 33.8; 53.9; 75.7; 0.0 | — |
| SECONDARY Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2. |
0.6; 0.0; 93.9; 90.5; 76.1; 57.7 | 0.358 |
| SECONDARY Change of CDAI and SDAI at Each Visit During Period 1. |
-16.78; -21.69; -25.77; -29.25; -18.19; -23.06 | — |
| SECONDARY Change of CDAI and SDAI at Each Visit During Period 2 |
-32.11; -32.23; -29.62; -26.49; -28.71; -24.33 | 0.049 sig |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit. |
58.6; 73.1; 83.6; 87.8; 19.8; 35.8 | — |
| SECONDARY Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit. |
96.3; 96.4; 91.3; 81.5; 88.2; 76.8 | 0.742 |
| SECONDARY Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts). |
-6.49; -8.59; -10.12; -11.50; -5.52; -7.04 | — |
| SECONDARY Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts). |
-12.65; -12.35; -11.69; -10.08; -11.22; -9.23 | 0.062 |
| SECONDARY Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1 |
-2.60; -3.46; -4.12; -4.79 | — |
| SECONDARY Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2 |
-5.28; -5.26; -4.93; -4.23; -4.83; -3.89 | 0.005 sig |
| SECONDARY Change in the Subject Global Assessment of Arthritis in Period 1 |
-2.18; -2.60; -3.32; -3.97 | — |
| SECONDARY Change in the Subject Global Assessment of Arthritis in Period 2 |
-4.39; -4.64; -4.03; -3.48; -4.02; -3.05 | 0.048 sig |
| SECONDARY Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1 |
-78.56; -90.58; -102.25; -109.32 | — |
| SECONDARY Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2 |
-118.30; -121.93; -134.42; -109.57; -132.05; -104.40 | 0.033 sig |
| SECONDARY Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1 |
-20.20; -25.17; -32.54; -40.67; -24.07; -28.55 | — |
| SECONDARY Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2 |
-46.66; -47.53; -41.31; -34.95; -39.84; -30.74 | 0.078 |
| SECONDARY Change in CRP and ESR at Each Visit During Period 1 |
-14.07; -14.43; -14.71; -14.51; -17.32; -19.28 | — |
| SECONDARY Change in CRP and ESR at Each Visit During Period 2 |
-16.92; -14.47; -15.94; -8.59; -15.56; -7.45 | 0.014 sig |
Summary
To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.
Eligibility Criteria
Inclusion Criteria
- Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
- Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.
Exclusion Criteria
- Subjects who used any of the following systemic treatments during the washout periods given below:
- Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
- Treatment with more than 1 NSAID within 14 days at baseline.
- Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
- Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
- Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
- Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
Data sourced from ClinicalTrials.gov (NCT01578850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.