Phase 3
Completed N=4,481
Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid Arthritis
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00413699 ↗
Enrolled (actual)
4,481
Serious AEs
29.9%
Results posted
Mar 2018
Primary outcomePrimary: Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports — 991; 2963; 3954; 159 Number of participants
◆ Published Evidence
Highly cited
116citations · ~39 / year
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance.
Summary
The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550
A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550
Linked Publications (5)
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Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance.
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Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib.
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Sex differences in the efficacy, safety and persistence of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of phase III and long-term extension 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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Determinants of tofacitinib discontinuation in adult patients with rheumatoid arthritis during long-term extension studies up to 9.5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports |
991; 2963; 3954; 159; 395; 554 | — |
| PRIMARY Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) |
16; 5 | — |
| PRIMARY Extension Period: Number of Participants With Laboratory Test Abnormalities |
30 | — |
| PRIMARY Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis |
1123; 3358; 4481; 59.4; 61.8; 61.2 | — |
| PRIMARY Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib |
31.3; 4.2; 17.6; 0 | — |
| SECONDARY Initial Period: Percentage of Patients With American College of Rheumatology (ACR) 20, 50, and 70 Responses |
70.65; 73.60; 72.86; 74.81; 76.06; 75.75 | — |
| SECONDARY Extension Period: Percentage of Participants With American College of Rheumatology (ACR) 20, 50, and 70 Responses |
70.21; 66.67; 86.67; 50.00; 48.94; 55.56 | — |
| SECONDARY Initial Period: Area Under American College of Rheumatology (ACR) n Curve |
— | — |
| SECONDARY Initial Period: Disease Activity Score (DAS)28 (C-reactive Protein [CRP]) and DAS28 (Erythrocyte Sedimentation Rate [ESR]) |
6.27; 6.39; 6.36; 3.81; 3.78; 3.79 | — |
| SECONDARY Extension Period: Change From Baseline in Disease Activity Score (DAS) 28-3 C-Reactive Protein (CRP)(DAS28-3 CRP) and DAS28-4 Erythrocyte Sedimentation Rate (ESR)(DAS28-4 ESR) at Month 3, 6, 9 and 12 |
5.68; -2.82; -3.02; -3.13; -2.55; 4.67 | — |
| SECONDARY Initial Period: Number (%) of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) <2.6 and ≤3.2 |
0.2; 0.3; 0.3; 19.9; 20.4; 20.3 | — |
| SECONDARY Extension Period: Percentage of Participants With DAS28-4 (ESR) and DAS28-3 (CRP) Less Than (<) 2.6 and Less Than or (<=) 3.2 |
12.5; 40.9; 45.7; 46.7; 50.0; 29.2 | — |
| SECONDARY Initial Period: Health Assessment Questionnaire - Disability Index (HAQ-DI) Score |
-0.57; -0.61; -0.60; -0.58; -0.65; -0.63 | — |
| SECONDARY Extension Period: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 3, 6, 9 and 12 |
1.35; -0.48; -0.55; -0.58; -1.50 | — |
| SECONDARY Initial Period: Short-Form-36 Health Survey (SF-36) Score |
7.90; 8.85; 8.60; 8.10; 9.02; 8.77 | — |
| SECONDARY Initial Period: FACIT Fatigue Scale, EuroQol EQ 5D, Work Limitations Questionnaire, and RA Healthcare Resource Utilization Questionnaire (RA-HCRU) |
6.29; 7.33; 7.19; 5.98; 7.33; 7.06 | — |
| SECONDARY Initial Period: Preservation of Joint Structure in Participants Who Had Baseline Radiographs Obtained in Their Qualifying Index Study |
20.55; 24.13; 23.84; 22.58; 25.12; 24.91 | — |
| SECONDARY Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Pneumococcal Vaccine as Defined by ≥ 2-fold Increase in Antibody Concentrations |
18.7; 38.5; 75.0; 84.6 | — |
| SECONDARY Vaccine Sub-study. Percent Achieving a Satisfactory Humoral Response to the Seasonal Influenza Vaccine as Defined by ≥ 4-fold Increase in Antibody Titers |
31.9; 53.8; 66.3; 63.7 | — |
| SECONDARY Vaccine Sub-study. Percentage of Participants Achieving Protective Antibody Titers to the Seasonal Influenza Vaccine as Measured by a Hemagglutination Inhibition (HI) Assay Titer of ≥ 1:40 in ≥ 2 of 3 Influenza Antigens at Vaccine Sub-study Visit 3 and 4 |
56.0; 69.2; 75.0; 82.4 | — |
| SECONDARY Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 12 Pneumococcal Antigens as Defined by ≥ 2-fold Increase in Antibody Concentrations From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 |
75; 82.4; 53.3; 71.4; 76.1; 76.9 | — |
| SECONDARY Vaccine Sub-study. Percentage of Participants Who Respond to Each of the 3 Influenza Antigens as Defined by ≥ 4-fold Increase in Antibody Titers From Vaccine Sub-study Visit 2 (Vaccination Baseline) Measured at Vaccine Sub-study Visit 4 |
45.7; 51.6; 71.7; 63.7; 66.3; 74.7 | — |
| SECONDARY Vaccine Sub-study. Fold Increase of Anti-pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 |
5.87; 9.26; 2.34; 4.20; 5.32; 6.29 | — |
| SECONDARY Vaccine Sub-study. Fold Increase of Anti-influenza Antibody Levels to Each of the 3 Influenza Antigens Above Vaccination Baseline Values (Vaccine Sub-study Visit 2) at Vaccine Sub-study Visit 4 |
3.33; 4.17; 7.94; 6.71; 7.80; 8.51 | — |
| SECONDARY Vaccine Sub-study. Concentrations of Anti-pneumococcal Antibodies at Vaccine Sub-study Visit 3 and 4 |
1.31; 1.12; 2.00; 2.26; 4.16; 4.80 | — |
| SECONDARY Vaccine Sub-study. Titers of Anti-influenza Antibodies at Vaccine Sub-study Visit 3 and 4 |
11.43; 10.85; 23.29; 37.45; 38.06; 45.19 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who have participated in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis
Vaccine sub-study visit
- Subjects actively participating in Study A3921024 must have completed at least 3 months of continuous 10 mg BID CP-690,550 treatment in A3921024 as defined by >80% compliance with prescribed dose consumption of CP-690,550 over the previous 3 months.
Exclusion Criteria
- Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
Vaccine sub-study visit
- Any documented influenza or pneumococcal infection within the last 3 months prior to randomization in this study
- Received any vaccine within 1 month prior to randomization in this study
- Received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of randomization in this study.
Data sourced from ClinicalTrials.gov (NCT00413699) 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.