Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-06 @ 10:55 PM
Study NCT ID:
NCT03414502
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2014-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'C000596027', 'term': 'baricitinib'}, {'id': 'D000068582', 'term': 'Certolizumab Pegol'}, {'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'C529000', 'term': 'golimumab'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}, {'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D000077339', 'term': 'Leflunomide'}, {'id': 'D008911', 'term': 'Minocycline'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C000592401', 'term': 'sarilumab'}, {'id': 'D012460', 'term': 'Sulfasalazine'}, {'id': 'C479163', 'term': 'tofacitinib'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2014-01-02', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis', 'timeFrame': '16 weeks', 'description': 'The efficacy of the disease-modifying antirheumatic drugs (DMARD) in the study will be determined using the American College of Rheumatology 50 (ACR50). This is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \\[most often Health Assessment Questionnaire (HAQ)\\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).'}], 'secondaryOutcomes': [{'measure': 'Genetic factors as Predictors of Disease-modifying Antirheumatic Drugs Response', 'timeFrame': '16 weeks', 'description': 'Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have genetic factors, such as the shared epitope, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).'}, {'measure': 'Serological Factors as Predictors of Disease-modifying Antirheumatic Drugs Response', 'timeFrame': '16 weeks', 'description': 'Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have serological factors, such as cyclic citrullinated peptide (CCP) isotypes, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).'}, {'measure': 'Co-morbid Conditions as Predictors of Disease-modifying Antirheumatic Drugs Response', 'timeFrame': '16 weeks', 'description': 'Based on American College of Rheumatology 50 (ACR50) composite measure after 16 weeks of treatment, the number of participants will be determined that have co-morbid conditions, such as periodontal disease, that demonstrate a 50% improvement in the number of tender and swollen joints, and a 50% improvement in three of five criteria: patient global assessment, physician global assessment, functional ability measure (most often Health Assessment Questionnaire/HAQ), visual analog pain scale and erythrocyte sedimentation rate or C-reactive protein (CRP).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methotrexate', 'DMARD'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.\n\nThis study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.', 'detailedDescription': 'Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.\n\nInvestigators have examined the discriminatory characteristics of several clinical and biologic parameters in predicting treatment response (at least 50% improvement based on American College of Rheumatology criteria), including rheumatoid factor (RF) isotypes (particularly Immunoglobulin A (IgA) and Immunoglobulin M (IgM), matrix metalloproteinase (MMP)-3, human leukocyte antigen-DR isotope (HLA-DRB1) shared epitope (SE)-containing alleles, C-reactive protein, and interleukin (IL)-1.\n\nThe purpose of the study is to prospectively gather information on participants with rheumatoid arthritis (RA) and their response to disease-modifying antirheumatic drugs (DMARD) therapy. Specifically, to evaluate the efficacy of DMARD therapy as defined by attaining American College of Rheumatology 50 (ACR50) response after 16 weeks of therapy and to identify predictors of DMARD response, such as genetic factors, serological factors or co-morbid conditions. A maximum of 400 rheumatoid arthritis (RA) participants will be enrolled in this 16-week, open-label study. Adult males and females will be enrolled, but RA is approximately three times more common in females.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria\n\n * Morning stiffness for at least 1 hour for at least 6 weeks\n * Swelling of 3 or more joints for at least 6 weeks\n * Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks\n * Symmetric joint swelling\n * Hand x-rays with erosions or bony decalcifications\n * RA nodules\n * Rheumatoid factor (RF) positive\n* \\>19 yrs old at RA diagnosis\n* Active disease with at least 1 swollen joint\n* Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)\n* If on other DMARDS, must be on stable dose for ≥ 6 wks\n* If on glucocorticoids, must be on stable dose for 2 wks (\\< 10mg of Prednisone/day or equivalent)\n* Able to adhere to study visit schedule: enrollment (8 wks \\& 16 wks +/- 2 wks)\n* Hemoglobin (Hgb) \\> 9g/dl\n* Platelets \\>100\n* Creatinine \\<1.6\n* Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit\n* Albumin up to 1.0 g/dL below lower limit of normal\n\nEXCLUSION CRITERIA:\n\n* Pregnant or breastfeeding women\n* Men and women of child bearing potential unwilling to practice effective method of contraception'}, 'identificationModule': {'nctId': 'NCT03414502', 'briefTitle': 'Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response', 'orgStudyIdInfo': {'id': '0439-23-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methotrexate Therapy', 'description': 'Participants will receive methotrexate therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept Therapy', 'description': 'Participants will receive abatacept therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Abatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adalimumab Therapy', 'description': 'Participants will receive adalimumab therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Adalimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azathioprine Therapy', 'description': 'Participants will receive azathioprine therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Azathioprine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Barcitinib Therapy', 'description': 'Participants will receive barcitinib therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Baricitinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Certolizumab Therapy', 'description': 'Participants will receive certolizumab therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Certolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Etanercept Therapy', 'description': 'Participants will receive etanercept therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Etanercept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Golimumab Therapy', 'description': 'Participants will receive golimumab therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Golimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxycholoroquine Therapy', 'description': 'Participants will receive hydroxychloroquine therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infliximab Therapy', 'description': 'Participants will receive infliximab therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Infliximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leflunomide Therapy', 'description': 'Participants will receive leflunomide therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Leflunomide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Minocycline Therapy', 'description': 'Participants will receive minocycline therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Minocycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rituximab Therapy', 'description': 'Participants will receive rituximab therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Rituximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sarilumab Therapy', 'description': 'Participants will receive sarilumab therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Sarilumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sulfasalazine Therapy', 'description': 'Participants will receive sulfasalazine therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Sulfasalazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tofacitinib Therapy', 'description': 'Participants will receive tofacitinib therapy for rheumatoid arthritis (RA) treatment.', 'interventionNames': ['Drug: Tofacitinib']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['Methotrexate (MTX)'], 'description': 'Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg daily.', 'armGroupLabels': ['Methotrexate Therapy']}, {'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Abatacept Therapy']}, {'name': 'Adalimumab', 'type': 'DRUG', 'otherNames': ['Humira'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Adalimumab Therapy']}, {'name': 'Azathioprine', 'type': 'DRUG', 'otherNames': ['Imuran'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Azathioprine Therapy']}, {'name': 'Baricitinib', 'type': 'DRUG', 'otherNames': ['Olimuant'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Barcitinib Therapy']}, {'name': 'Certolizumab', 'type': 'DRUG', 'otherNames': ['Cimzia'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Certolizumab Therapy']}, {'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Etanercept Therapy']}, {'name': 'Golimumab', 'type': 'DRUG', 'otherNames': ['Simponi'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Golimumab Therapy']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Hydroxycholoroquine Therapy']}, {'name': 'Infliximab', 'type': 'DRUG', 'otherNames': ['Remicade'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Infliximab Therapy']}, {'name': 'Leflunomide', 'type': 'DRUG', 'otherNames': ['Arava'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Leflunomide Therapy']}, {'name': 'Minocycline', 'type': 'DRUG', 'otherNames': ['Minocin'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Minocycline Therapy']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Rituxin'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Rituximab Therapy']}, {'name': 'Sarilumab', 'type': 'DRUG', 'otherNames': ['Kevzara'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Sarilumab Therapy']}, {'name': 'Sulfasalazine', 'type': 'DRUG', 'otherNames': ['Azulfidine'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Sulfasalazine Therapy']}, {'name': 'Tofacitinib', 'type': 'DRUG', 'otherNames': ['Xeljanz'], 'description': "Starting dose may be adjusted as needed at investigator's discretion.", 'armGroupLabels': ['Tofacitinib Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aimee B Schreiner, MS', 'role': 'CONTACT', 'email': 'aischreiner@unmc.edu', 'phone': '402-559-7288'}, {'name': 'Bridget E Kramer, RN', 'role': 'CONTACT', 'email': 'bridget.kramer@unmc.edu', 'phone': '402-559-7288'}, {'name': "James R O'Dell, MD", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'centralContacts': [{'name': 'Aimee B Schreiner, MS', 'role': 'CONTACT', 'email': 'aischreiner@unmc.edu', 'phone': '402-559-4873'}], 'overallOfficials': [{'name': "James R O'Dell, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}