Phase 2
Completed N=70
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Source: ClinicalTrials.gov NCT02969044 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 — 45.15; 44.85; -26.11; -17.38 units on a scale — p=<0.001
Summary
This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8 |
45.15; 44.85; -26.11; -17.38 | <0.001 sig |
| SECONDARY Number of Participants With Vital Signs Abnormalities |
3; 0; 0; 1 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities |
42; 28 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
20; 5; 0; 0 | — |
| SECONDARY Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6 |
-4.59; -4.52; -12.82; -8.05; -17.79; -12.55 | — |
| SECONDARY Remission Rate Based on Simple Disease Activity Index Score |
4.8; 0.0; 4.8; 0.0; 7.1; 0.0 | — |
| SECONDARY Remission Rate Based on Disease Activity Score (DAS28-3 [ESR]) |
4.8; 0.0; 2.4; 0.0; 7.1; 0.0 | — |
| SECONDARY Remission Rate Based on Disease Activity Score (DAS28-4[ESR]) |
4.8; 0.0; 4.8; 0.0; 7.1; 0.0 | — |
| SECONDARY Remission Rate Based on Disease Activity Score (DAS28-3 [CRP]) |
9.5; 0.0; 7.1; 3.6; 9.5; 0.0 | — |
| SECONDARY Remission Rate Based on Disease Activity Score (DAS28-4 [CRP]) |
9.5; 0.0; 9.5; 3.6; 9.5; 0.0 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8 |
6.49; 6.37; -0.19; -0.26; -0.67; -0.46 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8 |
6.82; 6.72; -0.27; -0.27; -0.83; -0.47 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8 |
5.76; 5.61; -0.35; -0.20; -0.86; -0.47 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8 |
6.11; 5.98; -0.41; -0.21; -0.99; -0.47 | — |
| SECONDARY Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8 |
2.00; 1.68; -0.20; 0.60; -0.62; -0.04 | — |
| SECONDARY Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8 |
16.74; 16.75; 12.95; 12.11; -1.54; -1.96 | — |
| SECONDARY Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8 |
66.64; 71.75; 68.43; 69.00; 66.17; 74.07 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8 |
1.79; 1.69; -0.13; -0.04; -0.26; -0.15 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects between the ages of 18 and 75 years, inclusive
- Must have moderate-to-severe, active Rheumatoid Arthritis
- Must have had an inadequate response to Methotrexate
- Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated
Exclusion Criteria
- Subjects with any acute or chronic infections or infection history
- Have acute or active chronic dermatological disorders prior to study start
- Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study
- Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency
- Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine
Data sourced from ClinicalTrials.gov (NCT02969044). 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.