Phase 2
Completed N=86
A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00938587 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 — 6.04; 6.14; 5.92; 6.03 units on a scale — p=0.0141
Summary
This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14 |
6.04; 6.14; 5.92; 6.03; -1.79; -2.22 | 0.0141 sig |
| SECONDARY Change From Baseline in Tender Joints Count at Day 7, 14, 42 |
17.10; 16.86; 15.05; 17.09; -5.14; -5.95 | 0.4370 |
| SECONDARY Change From Baseline in Swollen Joints Count at Day 7, 14 and 42 |
11.95; 11.73; 10.67; 11.64; -3.19; -5.19 | 0.8370 |
| SECONDARY Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42 |
20.24; 30.15; 20.02; 16.97; -13.78; -23.60 | 0.0599 |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14 |
1.76; 1.41; 1.62; 1.73; -0.24; -0.24 | 0.2403 |
| SECONDARY Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14 |
62.45; 60.49; 63.17; 66.65; -12.03; -16.95 | 0.6067 |
| SECONDARY Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14 |
60.71; 63.55; 65.89; 65.26; -16.05; -18.75 | 0.3579 |
| SECONDARY Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14 |
58.10; 62.27; 57.86; 59.87; -13.38; -20.42 | 0.5090 |
| SECONDARY Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14 |
29.92; 30.69; 29.14; 32.74; 4.52; 4.58 | 0.9624 |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42 |
5.80; 5.87; 5.59; 5.72; -1.07; -1.51 | 0.1090 |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7 |
-1.21; -1.63; -0.67; -0.55 | 0.0956 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14 |
28.57; 52.38; 14.29; 27.27; 55.56; 66.67 | 0.1460 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14 |
9.52; 19.05; 0.00; 0.00; 22.22; 47.62 | 0.1017 |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14 |
4.76; 4.76; 0.00; 0.00; 0.00; 14.29 | 0.2630 |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
8; 3; 4; 12; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Body Weight at Day 7 and 14 |
83.7; 74.1; 78.4; 75.0; 0.12; -0.04 | 0.5403 |
| SECONDARY Number of Participants With Clinically Significant Vital Signs Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0 | — |
| SECONDARY Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14 |
53.07; 136.8; 90.28; 257.9; 118.1; 281.3 | — |
| SECONDARY Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate |
1.24; 0.98; 1.14; 0.93 | — |
| SECONDARY Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14 |
1.85; 1.80; 1.68; 1.79; -0.01; 0.02 | — |
| SECONDARY Change From Baseline in Neutrophil Counts at Day 1, 7 and 14 |
5.43; 5.53; 5.90; 5.03; 0.04; 0.42 | — |
| SECONDARY Change From Baseline in Eosinophil Counts at Day 1, 7 and 14 |
0.19; 0.19; 0.20; 0.15; -0.02; -0.02 | — |
| SECONDARY Change From Baseline in Osteocalcin Level at Day 1, 7 and 14 |
21.76; 17.52; 29.36; 15.29; -1.78; -1.45 | — |
| SECONDARY Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14 |
106.85; 110.50; 106.38; 105.14; -26.40; -30.94 | — |
| SECONDARY Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14 |
63.56; 62.00; 77.75; 79.63; 7.94; 16.40 | — |
| SECONDARY Change From Baseline in Adiponectin Level at Day 7 and 14 |
7251.43; 8349.09; 7732.38; 10080.95; -434.21; 1664.76 | — |
Eligibility Criteria
Inclusion Criteria
- Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months
- On stable dose of methotrexate for at least 6 weeks prior to screening
- Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL
- Not currently receiving steroid medication
Exclusion Criteria
- Pregnant or nursing women
- Patients that have active infections, TB, HIV and/or Hepatitis B or C
- Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids
Data sourced from ClinicalTrials.gov (NCT00938587). 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.