Paroxetine Safety and Efficacy in Rheumatoid Arthritis

Launched by MOSTAFA BAHAA · Jan 20, 2024

Nctid: NCT06231745

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{"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008727", "term"=>"Methotrexate"}, {"id"=>"D000017374", "term"=>"Paroxetine"}], "ancestors"=>[{"id"=>"D000000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000000019", "term"=>"Abortifacient Agents"}, {"id"=>"D000012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000003879", "term"=>"Dermatologic Agents"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D000017367", "term"=>"Selective Serotonin Reuptake Inhibitors"}, {"id"=>"D000014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000018490", "term"=>"Serotonin Agents"}, {"id"=>"D000018687", "term"=>"Antidepressive Agents, Second-Generation"}, {"id"=>"D000000928", "term"=>"Antidepressive Agents"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000065690", "term"=>"Cytochrome P-450 CYP2D6 Inhibitors"}, {"id"=>"D000065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}], "browseLeaves"=>[{"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M19649", "name"=>"Selective Serotonin Reuptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M19654", "name"=>"Paroxetine", "asFound"=>"Biomarker analysis", "relevance"=>"HIGH"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-02-20", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-31", "studyFirstSubmitDate"=>"2024-01-20", "studyFirstSubmitQcDate"=>"2024-01-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-02-20", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The primary efficacy end point will be the change in the 28-joints disease activity score (DAS28).", "timeFrame"=>"3 months", "description"=>"A DAS28 value of greater than 5.1 indicates high disease activity. The values of 3.2 \\< DAS28 ≤ 5.1 and DAS28 ≤ 3.2 are indicative of moderate and low disease activities, respectively. If DAS28 value is less than 2.6, the patients may be considered to be in remission phase"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Rheumatoid Arthritis"]}, "descriptionModule"=>{"briefSummary"=>"Rheumatoid arthritis (RA) is a systemic chronic auto-inflammatory disorder which imposes a remarkable burden of morbidity and mortality on global health. The complex interaction between genetics, environment, and immunological response contribute to RA pathogenesis. Current treatment comprises conventional disease-modifying anti-rheumatic drugs (DMARDs) followed by biological DMARDs, if necessary, to achieve low disease activity or remission. Therapeutics used in RA had limitations in tolerability, access, and response duration and magnitude. Consequently, implementation of safe adjunctive treatment for RA is urgently needed to boost the therapeutic response."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"57 years", "minimumAge"=>"23 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged 23-57 years fulfilling 2010 American College of Rheumatology - European League against Rheumatism (ACR-EULAR) classification criteria for RA (12) and had active inflammatory RA with no limit in disease duration.\n* Patients received MTX, nonsteroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids will be allowed to enroll the trial\n* Intravenous, intra-articular or intramuscular corticosteroids; intra-articular hyaluronate sodium; biological DMARDs; and other DMARDs will not be permitted less than 4 weeks before the first dose of paroxetine.\n\nExclusion Criteria:\n\n* patients refusing to give informed consent, diabetes, congestive heart failure, previous adverse reaction to paroxetine, oral prednisolone greater than 10 mg/day, receiving biological DMARDs, severe anemia, active infection, pregnancy or lactation, and clinically significant renal or hepatic disease."}, "identificationModule"=>{"nctId"=>"NCT06231745", "briefTitle"=>"Paroxetine Safety and Efficacy in Rheumatoid Arthritis", "organization"=>{"class"=>"OTHER", "fullName"=>"Tanta University"}, "officialTitle"=>"The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients.", "orgStudyIdInfo"=>{"id"=>"314879"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"control group", "description"=>"group one (control group): 50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus placebo tablets", "interventionNames"=>["Drug: Methotrexate"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Comparative group", "description"=>"50 patients will receive the conventional DMARDs therapy (methotrexate 7.5 mg IM once weekly) plus 20 mg paroxetine daily", "interventionNames"=>["Drug: Methotrexate", "Drug: Paroxetine"]}], "interventions"=>[{"name"=>"Methotrexate", "type"=>"DRUG", "description"=>"Methotrexate (MTX) is an anti-metabolite most commonly used in chemotherapy and immunosuppressant in auto-immune diseases. This activity describes the indications, action, and contraindications for Methotrexate as a valuable agent in treating a wide variety of diseases.", "armGroupLabels"=>["Comparative group", "control group"]}, {"name"=>"Paroxetine", "type"=>"DRUG", "description"=>"Paroxetine is a type of antidepressant known as a selective serotonin reuptake inhibitor (SSRI). It's often used to treat depression, and sometimes obsessive compulsive disorder (OCD), panic attacks, anxiety or post-traumatic stress disorder (PTSD).", "armGroupLabels"=>["Comparative group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"34518", "city"=>"Damietta", "state"=>"New Damietta", "status"=>"RECRUITING", "country"=>"Egypt", "contacts"=>[{"name"=>"Mostafa Bahaa, PhD", "role"=>"CONTACT", "email"=>"mbahaa@horus.edu.eg", "phone"=>"0201025538337"}], "facility"=>"Mostafa Bahaa", "geoPoint"=>{"lat"=>31.41648, "lon"=>31.81332}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Mostafa Bahaa", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Teaching assisstant", "investigatorFullName"=>"Mostafa Bahaa", "investigatorAffiliation"=>"Tanta University"}}}}