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Phase 2b, Randomized, Multicenter, Double-blind, Parallel Group, Placebo Controlled, Dose Ranging Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT05279417
Title field or adapter rule
{'original_value': 'Phase 2b, Randomized, Multicenter, Double-blind, Parallel Group, Placebo Controlled, Dose Ranging Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At
2026-10-30T23:06:05.454466+00:00
Published At
2026-09-28T00:00:00+00:00
Record Updated At
2026-09-28
Results Posted At
2026-09-28
Source Retrieved At
2026-10-30T22:08:09.759186+00:00
Timestamp Basis
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation
ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Rheumatoid Arthritis"]
protocolSection.statusModule.lastUpdatePostDateStruct
{"date": "2026-09-28", "type": "ACTUAL"}
protocolSection.identificationModule.nctId
"NCT05279417"
protocolSection.identificationModule.officialTitle
"Phase 2b, Randomized, Multicenter, Double-blind, Parallel Group, Placebo Controlled, Dose Ranging Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ATI-450 Plus Methotrexate (MTX) Versus Placebo Plus MTX in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response to MTX Alone"
protocolSection.statusModule.overallStatus
"COMPLETED"
protocolSection.designModule.phases
["PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct
{"date": "2026-09-28", "type": "ACTUAL"}

Study condition terms

  • Rheumatoid Arthritis (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

  • {'armGroupLabels': ['ATI-450 50 mg BID plus Methotrexate'], 'description': 'Oral, small molecule MK2 inhibitor', 'name': 'ATI-450 50 mg oral tablet BID', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['Placebo plus Methotrexate'], 'description': 'Placebo tablet manufactured to match ATI-450 in appearance', 'name': 'Placebo oral tablet', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['ATI-450 20 mg BID plus Methotrexate', 'ATI-450 50 mg BID plus Methotrexate', 'Placebo plus Methotrexate'], 'description': '15 mg to 25 mg weekly', 'name': 'Methotrexate', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
  • {'armGroupLabels': ['ATI-450 20 mg BID plus Methotrexate'], 'description': 'Oral, small molecule MK2 inhibitor', 'name': 'ATI-450 20 mg oral tablet BID', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

  • ATI-450 50 mg oral tablet BID (protocolSection.armsInterventionsModule.interventions[].name)
  • Placebo oral tablet (protocolSection.armsInterventionsModule.interventions[].name)
  • Methotrexate (protocolSection.armsInterventionsModule.interventions[].name)
  • ATI-450 20 mg oral tablet BID (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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