Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT03424733
Status:
UNKNOWN
Last Update Posted:
2019-08-15
First Post:
2018-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D000075662', 'term': 'Injection Site Reaction'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005119', 'term': 'Extravasation of Diagnostic and Therapeutic Materials'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C428112', 'term': 'peginterferon beta-1a'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients in both arms first take Tylenol and then take Tylenol in combination with Prednisone.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flu-like symptoms', 'timeFrame': '12 to 16 weeks', 'description': 'Reduced flu-like symptoms from Plegridy injections due to taking both Tylenol and Prednisone prior to treatment. Flu-like symptoms are measured every 6 hours for 48 hours after injection by patients self reporting their muscle aches, temperature, chills, and fatigue on a Holy Name administered Flu-like symptom questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Injection site reactions', 'timeFrame': '12 to 16 weeks', 'description': 'Reduced injection site reactions from Plegridy injections due to taking both Tylenol and Prednisone prior to injection. Injection site reactions are reported to a clinical research assistant approximately one week after injection. If present, patients must record their injection site reactions using a Holy Name administered tape measurer in centimeters, as well as descriptive characteristics of the injection (location on body, swelling, redness, itching, and pain). The clinical research assistant records all of the data on an injection site reaction form.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['demyelination', 'relapse rate', 'Pegylated interferon beta-1a', 'side effects', 'flu-like symptoms', 'injection site reactions', 'prednisone'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '9633761', 'type': 'RESULT', 'citation': 'Rio J, Nos C, Marzo ME, Tintore M, Montalban X. Low-dose steroids reduce flu-like symptoms at the initiation of IFNbeta-1b in relapsing-remitting MS. Neurology. 1998 Jun;50(6):1910-2. doi: 10.1212/wnl.50.6.1910.'}, {'pmid': '17588298', 'type': 'RESULT', 'citation': 'Brandes DW, Bigley K, Hornstein W, Cohen H, Au W, Shubin R. Alleviating flu-like symptoms with dose titration and analgesics in MS patients on intramuscular interferon beta-1a therapy: a pilot study. Curr Med Res Opin. 2007 Jul;23(7):1667-72. doi: 10.1185/030079907x210741.'}, {'pmid': '15304586', 'type': 'RESULT', 'citation': 'Rio J, Nos C, Bonaventura I, Arroyo R, Genis D, Sureda B, Ara JR, Brieva L, Martin J, Saiz A, Sanchez Lopez F, Prieto JM, Roquer J, Dorado JF, Montalban X. Corticosteroids, ibuprofen, and acetaminophen for IFNbeta-1a flu symptoms in MS: a randomized trial. Neurology. 2004 Aug 10;63(3):525-8. doi: 10.1212/01.wnl.0000133206.44931.25.'}]}, 'descriptionModule': {'briefSummary': 'Some of the most common side effects of the multiple sclerosis drug Plegridy (pegylated interferon beta-1a) include flu-like symptoms and injection site reactions. Physicians often advise patients to take Tylenol or aspirin prior to injection, but in this study the investigators evaluated whether using a low dose of oral steroid in combination with Tylenol reduced flu-like symptoms and injection site reactions.', 'detailedDescription': 'Multiple Sclerosis (MS) is a chronic neurological disease characterized by demyelination of the brain and spine. Currently, there are several treatments designed to decrease the frequency of attacks and delay disease progression. One of these treatments, interferon beta, has shown the potential to decrease relapse rates by approximately 30%, but because the body quickly clears these proteins, patients require more frequent dosing. Another interferon therapy called pegylated interferon beta-1a (Plegridy) was released and it was shown to last longer in the body than interferon beta-1a. This is why Plegridy can be take by an injection into tissue under the skin once every 14 days. However, some of the most common side effects of interferon beta therapy include flu-like symptoms and injection skin reactions, which can often cause patients to want to stop treatment. Clinical practitioners often advise patients to take acetaminophen (Tylenol) or aspirin before the injection in order to prevent the onset or decrease the severity of flu-like symptoms. A previous study with patients taking interferon beta-1a showed that taking a low dose oral steroid (prednisone) in addiction to a medication like Tylenol reduced flu-like symptoms compared to just taking Tylenol by itself. Because Plegridy lasts longer in the body and has more convenient dosing for patients, researchers in this study decided to investigate whether taking prednisone in addition to acetaminophen before the injection would help decrease or prevent the occurrence of flu-like symptoms and injection site reactions in patients taking the therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed any form of MS (relapsing remitting, primary progressive, secondary progressive), any EDSS (expanded stability status scale) score\n\nExclusion Criteria:\n\n* prior allergic reaction to interferon products, congestive heart failure, elevated liver enzymes'}, 'identificationModule': {'nctId': 'NCT03424733', 'briefTitle': 'Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects', 'organization': {'class': 'OTHER', 'fullName': 'Holy Name Medical Center, Inc.'}, 'officialTitle': 'A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a', 'orgStudyIdInfo': {'id': 'US-PEG-16-10990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Current Plegridy Users', 'description': 'Members in this group have been previously titrated and are currently taking the pegylated interferon beta-1 (Plegridy) injection once every two weeks. These patients will complete a total of six study injections of Plegridy (125 micrograms) totaling a 12 week study duration. Subjects must take two 325mg tablets of Tylenol 1 hour prior to each study injection, and one 20mg Prednisone tablet 4-5 hours prior to injections two through six only.', 'interventionNames': ['Drug: Plegridy', 'Drug: Prednisone', 'Drug: Tylenol Pill']}, {'type': 'EXPERIMENTAL', 'label': 'New Plegridy Users', 'description': 'Members in this group have never taken the pegylated interferon beta-1a (Plegridy) injection, and so they must first by titrated by injecting with a 63 and 94 microgram Plegridy dose. Titrations, along with full dose injections (125 micrograms) occur every two weeks. Patients must take two 325mg tablets of Tylenol prior to each titration injection. The third study dosage involves subjects taking the full 125 microgram Plegridy dosage with two 325mg Tylenol tablets prior to injection. The final five study injections (four through eight) require patients to take two 325mg Tylenol tablets 1 hour prior to injection, and one 20mg Prednisone tablet 4-5 hours prior to injection.', 'interventionNames': ['Drug: Plegridy', 'Drug: Prednisone', 'Drug: Tylenol Pill']}], 'interventions': [{'name': 'Plegridy', 'type': 'DRUG', 'otherNames': ['Pegylated Interferon beta-1a'], 'description': 'Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose', 'armGroupLabels': ['Current Plegridy Users', 'New Plegridy Users']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Take one 20 milligram prednisone tablet four to five hours prior to injections two through six of the full 125 microgram Plegridy dose.', 'armGroupLabels': ['Current Plegridy Users', 'New Plegridy Users']}, {'name': 'Tylenol Pill', 'type': 'DRUG', 'otherNames': ['Acetaminophen'], 'description': 'Take two 325 milligram Tylenol tablets 1 hour prior to each Plegridy injection, irregardless of dosage.', 'armGroupLabels': ['Current Plegridy Users', 'New Plegridy Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mary Ann Picone, MD', 'role': 'CONTACT', 'email': 'M-picone@mail.holyname.org', 'phone': '201-837-0727'}], 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}], 'centralContacts': [{'name': 'Mary Ann Picone, MD', 'role': 'CONTACT', 'email': 'm-picone@mail.holyname.org', 'phone': '201-837-0727'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Holy Name Medical Center, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurologist', 'investigatorFullName': 'Mary Ann Picone, MD', 'investigatorAffiliation': 'Holy Name Medical Center, Inc.'}}}}