Phase 1
Completed N=41
Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00838565 ↗Enrolled (actual)
41
Serious AEs
7.5%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 9; 4; 4; 6 participants
Summary
This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Blood tests will be performed to measure the amount of drug and changes in measures of inflammation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
9; 4; 4; 6; 6; 5 | — |
| PRIMARY Number of Participants With Positive Anti-drug Antibodies Response |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax): Day 1 |
421.6; 4631; 11320; 42290; 66280 | — |
| PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1 |
0.0521; 0.0521; 0.0521; 0.0521; 0.0521 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1 |
1899; 19570; 54140; 206000; 348500 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax): Day 28 |
617.6; 4719; 13680; 57280; 158300 | — |
| PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28 |
0.0521; 0.0521; 0.0521; 0.0521; 0.0521 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28 |
3104; 21660; 76510; 316900; 767900 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax): Day 56 |
741.0; 4424; 19650; 64850; 164600 | — |
| PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56 |
0.0521; 0.0521; 0.0521; 0.0521; 0.0521 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56 |
3730; 23200; 101100; 389100; 912200 | — |
| PRIMARY Serum Decay Half-Life (t1/2): Day 56 |
45.50; 36.90; 45.30; 38.80; 51.70 | — |
Eligibility Criteria
Inclusion Criteria
- Rheumatoid Arthritis on a stable dose of methotrexate
- Rheumatoid Arthritis disease activity as assessed by blood tests
Exclusion Criteria
- Serious or uncontrolled medical conditions
- Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
- Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent
Data sourced from ClinicalTrials.gov (NCT00838565). 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.