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Tasocitinib plus Methotrexate

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Apr 22, 2015

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment109

FDA Designations

No designations recorded

Clinical trial landscape

Tasocitinib plus Methotrexate · 1 trial · 1 indication

Phase 2 1
NCT01164579Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)Rheumatoid Arthritis
COMPLETED109 Analytics
PHASE2COMPLETED
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to Month 3 in Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) Wrist and Metacarpophalangeal (MCP) Synovitis
Month 3

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.

Change From Baseline to Month 6 in OMERACT RAMRIS Wrist and MCP Bone Marrow Edema
Month 6

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.

Secondary Endpoints

Change From Baseline to Months 1, 6, and 12 in OMERACT RAMRIS Wrist and MCP Synovitis
Months 1, 6, and 12
Change From Baseline to Months 1, 3, and 12 in OMERACT RAMRIS Bone Marrow Edema in Wrist and MCP
Months 1, 3, and 12
Change From Baseline to Months 1, 3, 6, and 12 in OMERACT RAMRIS Wrist and MCP Erosions
Months 1, 3, 6, and 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tofacitinib (CP 690,550) 10 mg BID plus MTXEXPERIMENTAL -
Tofacitinib (CP-690,550) 10 mg BID, tablet plus placebo MTXEXPERIMENTAL -
Placebo tofacitinib (CP-690,55) plus MTX 10 mg/wk to 20 mg/wkACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Tasocitinib plus MethotrexateDRUGTofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months
Tofacitinib plus placebo methotrexateDRUGTofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.
Placebo tofacitinib plus MethotrexateDRUGMethotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

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...

Countries:United StatesArgentinaChileCroatiaCzechiaHungaryMexicoPolandPuerto Rico
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Frequently asked questions about Tasocitinib plus Methotrexate

What is Tasocitinib plus Ketoconazole?

Tasocitinib plus Ketoconazole is an investigational combination studied in healthy volunteers and in patients with rheumatoid arthritis. Tasocitinib, also known as CP-690,550, is a small molecule developed by Pfizer. The combination was evaluated in Phase 1 and Phase 2 clinical trials to assess drug absorption and potential interactions.

What is Tasocitinib plus Ketoconazole used for?

Tasocitinib plus Ketoconazole was studied for use in healthy volunteers to evaluate pharmacokinetic interactions and in patients with early rheumatoid arthritis to assess joint structure changes via MRI. The combination is investigational and not approved for any indication.

Who makes Tasocitinib plus Ketoconazole?

Tasocitinib plus Ketoconazole is developed by Pfizer, Inc., traded on the New York Stock Exchange under the ticker PFE. Pfizer conducted clinical trials of this combination in healthy subjects and in patients with rheumatoid arthritis.

What phase is Tasocitinib plus Ketoconazole in?

Tasocitinib plus Ketoconazole has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials evaluated drug absorption and the effect of ketoconazole on tasocitinib pharmacokinetics in healthy volunteers. The Phase 2 trial assessed MRI-measured joint structure in early rheumatoid arthritis. It remains investigational.

What clinical trials is Tasocitinib plus Ketoconazole in?

Tasocitinib plus Ketoconazole has three completed trials: NCT01143805, a Phase 1 study of CP-690,550 tablet absorption in healthy subjects in Singapore; NCT01164579, a Phase 2 MRI study in early rheumatoid arthritis across multiple countries; and NCT01202240, a Phase 1 study of ketoconazole's effect on tasocitinib pharmacokinetics in healthy volunteers in Belgium.

Is Tasocitinib the same as CP-690,550?

Yes, Tasocitinib is also known as CP-690,550. Clinical trial records refer to the drug as CP-690,550, and the combination with ketoconazole is sometimes called Tasocitinib plus Ketoconazole. This naming appears in Pfizer's pharmacokinetic and efficacy studies.