Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tasocitinib
Tasocitinib plus Ketoconazole · 1 trial · 1 indication
Synovitis is defined as an area in the synovial compartment that shows above normal postgadolinium enhancement of a thickness greater than the width of the normal synovium. T1-weighted images were acquired before and after the administration of intravenous contrast agent containing gadolinium. Intravenous contrast was required to demonstrate enhancing synovitis. Synovitis was scored 0 to 3 in 3 wrist regions and in each of the first through fifth MCP joints. A score of 0 is normal, with no enhancement or enhancement up to the thickness of normal synovium, while scores of 1 to 3 (mild, moderate, severe) refer to increments of one-third of the presumed maximum volume of enhancing tissue in the synovial compartment. Total synovitis score ranges from a minimum of 0 to a maximum of 24. A negative value in synovitis change from Baseline score indicates an improvement.
Bone edema was assessed at 25 anatomic locations: 15 in 1 wrist and 10 in attached hand. Bone edema was defined as a lesion within the trabecular bone, with ill-defined margins and signal characteristics consistent with increased water content. Each bone was scored separately; the scale was 0-3 based on the proportion of bone with edema, as follows 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. OMERACT RAMRIS total bone edema score for hands/wrists was sum of the individual scores for each location. Thus the maximum score per hand/wrist was 75 (range 0-75). Increasing score=greater severity.
| Arm | Type | Description |
|---|---|---|
| Tofacitinib (CP 690,550) 10 mg BID plus MTX | EXPERIMENTAL | - |
| Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTX | EXPERIMENTAL | - |
| Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wk | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Tasocitinib plus Methotrexate | DRUG | Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months |
| Tofacitinib plus placebo methotrexate | DRUG | Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1. |
| Placebo tofacitinib plus Methotrexate | DRUG | Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib |
Inclusion Criteria: * Adult patients with moderate to severe early rheumatoid arthritis (\< 2 years) who are methotrexate and biologic disease modifying antirheumatic drug naive. Exclusion Criteria: * Pregnant or lactating patients; * Patients with renal or hepatic impairment or other severe or p...
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Tasocitinib plus Ketoconazole refers to a drug interaction study pairing tasocitinib, an oral small molecule kinase inhibitor, with ketoconazole. It is not a fixed combination product. The pairing was evaluated to understand how ketoconazole affects tasocitinib exposure in humans. Tasocitinib is being developed by Pfizer for rheumatoid arthritis.
Tasocitinib plus Ketoconazole is studied in rheumatoid arthritis, an autoimmune condition causing joint inflammation and damage. The ketoconazole component is used as a pharmacokinetic probe rather than as a treatment for arthritis. The pairing helps characterize how tasocitinib is metabolized when co-administered with a strong CYP3A4 inhibitor.
Tasocitinib targets Janus kinases, a family of intracellular kinases that mediate cytokine signaling. It belongs to the -tinib kinase inhibitor class. By inhibiting JAK enzymes, tasocitinib modulates inflammatory cytokine pathways involved in rheumatoid arthritis. Ketoconazole is not a kinase inhibitor and is used to assess drug-drug interaction potential.
Pfizer, Inc. (ticker: PFE) is the developer of tasocitinib and conducted the clinical study evaluating its co-administration with ketoconazole. Pfizer is a global pharmaceutical company. The tasocitinib program is part of Pfizer's immunology portfolio.
Tasocitinib plus Ketoconazole has been evaluated in Phase 2 clinical development. The drug is investigational and has not been approved by the FDA for any indication. The completed Phase 2 trial enrolled 109 participants with rheumatoid arthritis.
Tasocitinib plus Ketoconazole has been studied in one completed Phase 2 trial, NCT01164579, titled Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)-Assessed Joint Structure In Early Rheumatoid Arthritis (RA). The trial enrolled 109 participants across the United States, Argentina, Chile, Croatia, Czechia, Hungary, Mexico, Poland, and Puerto Rico.
Tasocitinib plus Ketoconazole is not the same as tasocitinib alone. Tasocitinib, also known as CP-690,550, is the active drug. The ketoconazole pairing denotes a drug interaction study. Other listed names include Tasocitinib plus Rifampin, Tasocitinib 10 mg oral tablet, and Tasocitinib plus Methotrexate, which refer to different study combinations or formulations.