Phase 4
Completed N=1,146
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Rhematoid Arthritis
Source: ClinicalTrials.gov NCT02187055 ↗
Enrolled (actual)
1,146
Serious AEs
7.5%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 — 38.28; 46.01; 43.78 Percentage of participants — p=0.2101
◆ Published Evidence
Emerging
10citations · ~5 / year
Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials.
Summary
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
Linked Publications (5)
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Tofacitinib Efficacy in Patients with Rheumatoid Arthritis and Probable Depression/Anxiety: Post Hoc Analysis of Phase 3 and 3b/4 Randomized Controlled Trials.
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Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib.
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Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials.
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Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention.
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Efficacy and Safety of Tofacitinib and Adalimumab in Rheumatoid Arthritis by Body Mass Index-Normalized Methotrexate Dose: A Post Hoc Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 |
38.28; 46.01; 43.78 | 0.2101 |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 |
-23.7; -26.6; -25.6 | — |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 |
-22.9; -25.5; -24.8 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 |
-2.1; -2.5; -2.3 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 |
-2.1; -2.4; -2.4 | — |
| SECONDARY Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 |
7.54; 8.67; 9.58 | — |
| SECONDARY Percentage of Participants Achieving SDAI ≤3.3 at Month 6 |
10.64; 13.91; 14.37 | — |
| SECONDARY Percentage of Participants Achieving CDAI ≤2.8 at Month 6 |
10.89; 14.70; 14.57 | — |
| SECONDARY Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 |
11.33; 12.79; 13.58 | — |
| SECONDARY Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 |
22.69; 32.75; 30.17 | — |
| SECONDARY Percentage of Participants Achieving SDAI ≤11 at Month 6 |
46.78; 53.33; 51.15 | — |
| SECONDARY Percentage of Participants Achieving CDAI ≤10 at Month 6 |
45.53; 52.45; 50.00 | — |
| SECONDARY Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6 |
22.10; 28.49; 29.77 | — |
| SECONDARY Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6 |
44.54; 49.57; 50.86 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 |
70.06; 79.13; 77.65 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 |
19.66; 27.11; 22.64 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 |
-0.52; -0.58; -0.54 | — |
| SECONDARY Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 |
71.07; 75.57; 72.86 | — |
| SECONDARY Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 |
6.7; 7.9; 7.8 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 |
5.2; 5.7; 4.4 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 |
6.4; 7.3; 7.3 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 |
6.7; 7.0; 6.3 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 |
8.2; 10.3; 9.9 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 |
5.1; 6.3; 5.4 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 |
5.6; 6.1; 5.7 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 |
6.3; 7.2; 6.2 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 |
6.7; 7.7; 6.0 | — |
| SECONDARY Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 |
5.3; 5.5; 5.0 | — |
| SECONDARY Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 |
-2.62; -2.19; -1.75; 0.14; 0.43; -0.77 | — |
| SECONDARY Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 |
0.20; 0.22; 0.22; -0.29; -0.26; -0.28 | — |
| SECONDARY Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 |
7.14; 7.59; 6.07 | — |
Eligibility Criteria
Inclusion Criteria
- Have moderate to severe rheumatoid arthritis
- On methotrexate but inadequately controlled
- Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
- Subjects must use contraception
Exclusion Criteria
- Subjects who have been previously treated with adalimumab or Tofacitinib
- Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Subjects with specific laboratory test abnormalities
- Subjects with specific types of infections
Data sourced from ClinicalTrials.gov (NCT02187055) and the linked publication. 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. Informational only — not medical advice.