- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01027728
Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid Arthritis (CARAT-1)
A Randomized, Double-Blind, Placebo-Controlled, Phase I/II Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis
Study Overview
Detailed Description
This randomized, double-blind, placebo-controlled Phase I/II study will consist of two sequential stages, Stage A and B. This protocol describes the objectives, design, and procedures for Stage A of the study. The protocol will be amended in future when sufficient data from Stage A have been collected to initiate Stage B. The protocol amendment will describe the objectives, design, and procedures for Stage B of the study.
Stage A will be a randomized, double-blind, placebo-controlled, multi-dose, sequential dose escalation sub-study in 24 subjects with stable RA. Three sequential dose cohorts of 8 subjects will be included in this stage:
- Cohort 1: 100 mg CCX354-C or placebo
- Cohort 2: 100 mg CCX354-C or placebo
- Cohort 3: 200 mg CCX354-C or placebo
Safety and PK data from each cohort will be reviewed by a data monitoring committee (DMC)before dose escalation to the next dose level. The study will proceed to Stage B only if the safety and tolerability profile of Stage A is deemed acceptable by the DMC.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female subjects, aged 18-75 years inclusive, with stable RA based on American College of Rheumatology (ACR) criteria (see section 11.3) for at least 3 months (subjects do not need to have active RA for Stage A of the study);
- Subjects must have been on a stable dose of methotrexate (7.5 to 25 mg/week) taken orally, subcutaneously, or intramuscularly, but not intravenously, for ≥ 8 weeks prior to randomization;
- If a subject is also taking sulfasalazine or hydroxychloroquine, the subject must have been on a stable dose of these medications for at least 8 weeks prior to randomization;
- If a subject is on corticosteroid therapy, the dose must not exceed 10 mg prednisone or equivalent and the subject must have been on a stable dose for at least 4 weeks prior to randomization;
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
- Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, and the hepatitis C screen;
- Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments;
- Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication. Adequate contraception is defined as usage by at least one of the partners of a barrier method of contraception, together with usage by the female partner, commencing at least three months prior to Screening, of a stable regimen of any form of hormonal contraception or an intra-uterine device. Use of abstinence alone is not considered adequate. Use of a barrier method alone is considered adequate only if the male partner was vasectomized at least six months prior to Screening. Use of a double-barrier method of contraception is acceptable.
Exclusion Criteria:
- Diagnosed with RA prior to 16 years of age;
- Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at Screening;
- History within one year prior to randomization of illicit drug use;
- History of alcohol abuse at any time in the past;
- Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomization;
- Use of leflunomide within 6 months of randomization;
- Use of etanercept or anakinra within 4 weeks of randomization;
- Use of rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomization;
- Currently taking cytochrome P450 inhibitors including protease inhibitors such as ritonavir,indinavir, nelfinavir, or macrolide antibiotics such as erythromycin, telithromycin,clarithromycin, or azole antifungals such as fluconazole, ketoconazole, itraconazole, or cimetidine, nefazodone, bergamottin (constituent of grapefruit juice), quercetin, aprepitant,or verapamil;
- History or presence of any form of cancer within the 10 years prior to randomization, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;
- Evidence of tuberculosis based on chest X rays, tuberculin skin test, QuantiFERON®-TB Gold test, or T-SPOT®.TB test performed during screening;
- Presence of Felty's syndrome, psoriatic arthritis, or other auto-immune diseases;
- Major surgery (including joint surgery) within 12 weeks prior to randomization;
- Subject's hemoglobin is less than 11 g/dL (6.83 mmol/L) at Screening;
- Subject has any evidence of hepatic disease; AST, ALT, alkaline phosphatase, or bilirubin > 1.5 x the upper limit of normal;
- Subject has any evidence of renal impairment; serum creatinine > 1.5 x upper limit of normal;
- The subject had an infection requiring antibiotic treatment within 4 weeks of randomization;
- History or presence of any medical or psychiatric condition or disease, or laboratory abnormality that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study; and
- Participated in any clinical study of an investigational product within 30 days prior to randomization.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CCX354-C
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subject Incidence of Adverse Events
Time Frame: 14 Days
|
14 Days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate possible interaction with methotrexate at a number of dose levels in subjects with stable RA
Time Frame: 14 Days
|
14 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: MD, Amgen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL003_354
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
Clinical Trials on CCX 354-C
-
ChemoCentryxCompletedRheumatoid ArthritisPoland, Germany, Belgium, Romania, Ukraine, Netherlands, Hungary, Czechia
-
MedImmune LLCAstraZeneca; MedImmune LtdCompleted
-
Global Alliance for TB Drug DevelopmentTerminated
-
Global Alliance for TB Drug DevelopmentCompleted
-
MedImmune LLCCompleted
-
MedImmune LLCCompletedAsthmaBulgaria, United Kingdom, Germany, Poland, Romania
-
MedImmune LLCCompleted
-
MedImmune LLCTerminatedModerate AsthmaUnited Kingdom
-
MedImmune LLCCompletedAsthma | Healthy Subjects or VolunteersUnited States
-
MedImmune LLCPRA Health Sciences; Cambridge Antibody TechnologyTerminatedAsthmaNetherlands, United Kingdom, Australia, Germany, Poland