Rheumatoid Arthritis Clinical Trial
Official title:
A Two-Part, Phase I Randomized, Double-Blind, Active-Comparator Controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of MK-8808 and to Compare the Pharmacokinetics of MK-8808 With Rituximab (MabThera™ and Rituxan™) in Patients With Rheumatoid Arthritis (RA)
Verified date | April 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Ukraine: Ministry of Health |
Study type | Interventional |
This is a study of the overall safety, tolerability, and pharmacokinetics (PK) of MK-8808 versus rituximab (MabThera™ and Rituxan™) and in participants with moderate to severe rheumatoid arthritis (RA) concomitantly treated with methotrexate. Participants will be enrolled in two parts and analysis of data from Part A will be performed while Part B is enrolling. Participants will receive one or two courses of therapy, with each course including two infusions of study drugs.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Female participants of reproductive potential must demonstrate a serum ß-hCG level consistent with the nongravid state at the prestudy (screening) visit, and a negative urine pregnancy test within 24 hours prior to all doses and and agree to use (and/or have their partner use) two acceptable methods of birth control beginning at least 2 weeks prior to administration of the first dose of study drug, throughout the study (including washout intervals between treatment periods/panels) and until at least 12 months after administration of the last dose of study drug in the last treatment period - The participant has a Body Mass Index (BMI) =35 kg/m2 at the prestudy (screening) visit - For Part A Only: The participant has a BSA =2.0 m2 at the prestudy (screening) visit. - Has satisfied at least 4 of 7 American Rheumatology Association (ARA) 1987 revised criteria for the diagnosis of rheumatoid arthritis - Is American College of Rheumatology (ACR) Functional Class I, II, or III - Had a diagnosis of RA made at least 6 months prior to the prestudy (screening) visit, was = 16 years of age when diagnosed, and has active disease - Is on a stable oral, intramuscular, or subcutaneous dose of methotrexate and is continuing to take methotrexate - Has an inadequate response or intolerance to at least one disease-modifying antirheumatic drug (DMARD) - For Part A: Participant is either naïve to biological therapy for RA or has had an inadequate response to previous or current treatment with an anti-TNF treatment (patient could have failed up to three anti-TNF agents treatments) or participant has had intolerance up to three anti-TNF treatments. - For Part B: Participant has had an inadequate response to previous or current treatment with an anti-TNF treatment (patient could have failed up to three anti-TNF agents treatments) or participant has had intolerance up to three anti-TNF treatments - Participant has no clinically significant abnormality on electrocardiogram (ECG) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug - For Part B Only: Participant is positive for rheumatoid factor (RF) or, if negative for RF, is positive for anti-CCP at screening visit - For Part C Only: Participant must have completed the first 52 weeks of treatment in the base study - For Part C Only: Participant achieved a minimum 20% response from baseline on the American College of Rheumatology (ACR) Responder Index (ACR20) at Visit 19 (last visit for the base study) Exclusion Criteria: - Mentally or legally incapacitated, has significant emotional problems at the time of the prestudy (screening) visit or during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years - Creatinine clearance of = 80 mL/min - History of stroke, chronic seizures or major neurological disorder - History of neoplastic disease, except treated basal cell carcinoma or carcinoma in situ or other malignancies which have been successfully treated = 5 years - History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disease regardless of the time since treatment - History of coronary artery disease, congestive heart failure (New York Heart Association Class I-IV), or a history of clinically significant arrhythmia (including any history of atrial fibrillation, atrial flutter, or any sustained ventricular arrhythmia) - Hypersensitivity or allergy to rituximab or any of the excipients of MK-8808 or rituximab (MabThera™ or Rituxan™) - History of a rheumatic autoimmune disease other than RA (e.g. systemic lupus erythematosus (SLE), polymyositis, etc.) - Severe active infection of any type or history of a medically serious infection as defined by a history of treatment requiring hospitalization, long term intravenous (IV) outpatient treatment for systemic bacterial, viral or fungal infection, use of I.V. antibiotics within 30-days of screening, or use of antibiotic therapy three or more times in the last six months prior to screening - History of opportunistic infection - Active-virus vaccination within 4 weeks - Active tuberculosis with or without adequate treatment, history of latent tuberculosis without written confirmation from health care provider of adequate prophylaxis or any evidence of tuberculosis on a chest X-ray (CRX) performed within 3 months of dosing - Chronic hepatitis B or hepatitis C infection or has human immunodeficiency virus (HIV) infection - Previously treated with rituximab (MabThera™ or Rituxan™) or any investigational anti-CD20 antibody - Active use or planned use of a prohibited DMARD during the course of study participation, and/or insufficient washout from a prohibited DMARD at the time of the planned first dose of MK-8808/rituximab (MabThera™ or Rituxan™) - Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks - Participated in another investigational study with length of time within at least 5 half-lives of the previous investigational study drug - Pregnant or breastfeeding or expecting to conceive - Allergy to murine proteins - Allergy or sensitivity to components of the drug vial or any of the materials used for infusion |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve from Day 0 to Day 84 (AUC[0-84day]) after a single course of treatment-Part A | Day 0 to Day 84 (Part A) | No | |
Primary | Area Under the Curve from Day 0 to Day 84 (AUC[0-84day]) after a single course of treatment-Part B | Day 0 to Day 84 (Part B) | No | |
Primary | Number of Participants with Adverse Events (AEs)-Part C | Week 52 to Week 106 | Yes | |
Primary | Number of Participants Discontinuing Treatment Due to AEs-Part C | Week 52 to Week 106 | Yes | |
Secondary | Maximum concentration (Cmax) after the second infusion of a single course of treatment-Part A | Day 15 | No | |
Secondary | Cmax after the second infusion of a single course of treatment-Part B | Day 197 | No |
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