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 RITUXIMUB (MAB THERA TM AND RITUXAN TM) IN PATIENTS WITH RHEUMATOID ARTHRITIS (RA)

Not Applicable

• Registration Number: PER-080-12
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-22
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. PATIENT IS A MALE OR FEMALE, BETWEEN 18 TO 65 YEARS OF AGE (INCLUSIVE) AT THE PRESTUDY (SCREENING) VISIT.
2. FEMALE PATIENTS OF REPRODUCTIVE POTENTIAL MUST DEMONSTRATE A SERUM β-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 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 MONTH S AFTER ADMINISTRATION OF THE LAST DOSE OF STUDY DRUG IN THE LAST TREATMENT PERIOD. ACCEPTABLE METHODS OF BIRTH CONTROL INCLUDE TWO (2) OF THE FOLLOWING: HORMONAL, CONTRACEPTION, INTRAUTERINE DEVICE (IUD-WITH OR WHITOUT LOCAL HORMONE RELAESE), DIAPHRAGM, SPERMICIDES, CERVICAL CAP, CONTRACEPTIVE SPONGE, AND/OR CONDOMS. ABSTINENCE IS AN ALTERNATIVE LIFE STYLE AND PATIENTS PRACTICING ABSTINANCE MAY BE INCLUDED IN THE STUDY. FEMALE PATIENTS OF NON-REPRODUCTIVE POTENTIAL ARE DEFINED AS EITHER:
I. REACHED NATURAL MENOPAUSE (DEFINED AS 6 MONTJS OF SPONTANEOUS AMENORRHEAWITH SERUM FSH LEVELS IN THE POSTMENOPAUSAL RANGE AS DETERMINED BY THE

Exclusion Criteria

1. PATIENT IS UNDER AGE 18 AND/OR THE LOCAL AGE OF LEGAL CONSENT
2. PATIENT IS MENTALLY OR LEGALLY INCAPACITATED (INCLUDING THOSE PERSONS KEPT IN DETENTION), 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. PATIENTS WHO HAVE HAD SITUACIONAL DEPRESSION MAY BE ENROLLED IN THE STUDY AT THE DISCRETION OF THE INVESTIGATOR.
MEDIACL HISTORY, PHYSICAL EXAMINATIONS, LABORATORY SAFETY TESTS AND ECG MEASUREMENTS
3. PATIENTS HAS AN ESTIMATED CREATININE CLEARENCE OF ≤ 80 ML/MIN BASED ON THE COCKCROFT-GAULT EQUATION; THE COCKCROFT-GAULT EQUATION IS:
CLCR = (140-AGE[YR])(BODY WT [KG])
(72)(SERUM CREAT [MG/DL])
WHEN CREATININE IS MEASURED IN MICROMOLE/LITRE, USE THE FOLLOWING FORMULA:
CLCR = (140-AGE[YR])(BODY WT [KG])
(0,82)(SERUM CREATININE [µMOL/L])
MULTIPLY RESULT BY 0.85 FOR WOMEN (APPLIES TO BOTH FORMULAS)

Study & Design

• Study Type: Interventional
• Study Design: Not specified