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Clinical Trials/ISRCTN50655730
ISRCTN50655730
Completed
Phase 1

A randomised, double-blind, placebo-controlled, phase I/II study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis

ChemoCentryx, Inc. (USA)0 sites24 target enrollmentFebruary 19, 2010
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ConditionsRheumatoid arthritisMusculoskeletal DiseasesOther rheumatoid arthritis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Rheumatoid arthritis
Sponsor
ChemoCentryx, Inc. (USA)
Enrollment
24
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 19, 2010
End Date
March 30, 2010
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ChemoCentryx, Inc. (USA)

Eligibility Criteria

Inclusion Criteria

  • •1\. Male or female subjects, aged 18 \- 75 years inclusive, with stable RA based on American College of Rheumatology (ACR) criteria for at least 3 months (subjects do not need to have active RA for Stage A of the study)
  • •2\. 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 greater than or equal to 8 weeks prior to randomisation
  • •3\. 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 randomisation
  • •4\. 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 randomisation
  • •5\. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
  • •6\. Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, and the hepatitis C screen
  • •7\. Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram \[ECG]), and clinical laboratory assessments
  • •8\. 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

  • •1\. Diagnosed with RA prior to 16 years of age
  • •2\. Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at Screening
  • •3\. History within one year prior to randomisation of illicit drug use
  • •4\. History of alcohol abuse at any time in the past
  • •5\. Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomisation
  • •6\. Use of leflunomide within 6 months of randomisation
  • •7\. Use of etanercept or anakinra within 4 weeks of randomisation
  • •8\. Use of rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomisation
  • •9\. 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
  • •10\. History or presence of any form of cancer within the 10 years prior to randomisation, 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

Outcomes

Primary Outcomes

Not specified

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