A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy (CARAT-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx
ClinicalTrials.gov Identifier:
NCT01242917
First received: November 15, 2010
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

This is a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: CCX-354-C
Drug: Placebo
Drug: CCX354-C
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy

Resource links provided by NLM:


Further study details as provided by ChemoCentryx:

Primary Outcome Measures:
  • Subject incidence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The change from baseline to week 12 of Disease Activity Score for 28 Joints using C-reactive proteine (DAS28-CRP) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 159
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Placebo film-coated tablets twice daily for 12 weeks + methotrexate
Experimental: CCX354-C 100mg twice daily Drug: CCX354-C
100mg film-coated tablets twice daily for 12 weeks + methotrexate
Experimental: CCX354-C 200mg once daily Drug: CCX-354-C
200mg film-coated tablets once daily for 12 weeks + Methotrexate

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects, aged 18-75 years inclusive, with functional class I to III rheumatoid arthritis (RA) based on American College of Rheumatology (ACR) criteria for at least 3 months prior to screening; wheel-chair bound subjects or those with irreversible disease will not be eligible;
  2. Subjects must have active RA, defined by a minimum of 8 swollen joints and 8 tender/painful joints (based on 66/68 joint count), at screening
  3. Serum C-reactive protein (CRP) above 5 mg/L at screening;
  4. Must have been on methotrexate (7.5 to 25 mg/week) taken orally, subcutaneously, or intramuscularly for ≥ 16 weeks and on a stable dose for ≥ 8 weeks prior to randomization;
  5. If on hydroxychloroquine, must have been on a stable dose for ≥ 16 weeks prior to randomization;
  6. If taking non-steroidal anti-inflammatory drugs (NSAIDs), must have been on stable doses for ≥ 2 weeks before randomization;
  7. If taking oral corticosteroids, subjects may not take more than 10 mg/day of prednisone or equivalent, and must have been on a stable dose for ≥ 4 weeks before randomization;
  8. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
  9. Negative result of the human immunodeficiency virus (HIV) screen, the hepatitis B screen, and the hepatitis C screen;
  10. Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments;
  11. 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 administration of study medication

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 randomization of illicit drug use;
  4. History of alcohol abuse at any time in the past;
  5. Have received sulfasalazine, azathioprine, 6-mercaptopurine, mycophenolate mofetil, tetracycline, cyclosporine, gold, tacrolimus, sirolimus, or other disease modifying anti-rheumatic drug (DMARD) within 8 weeks of randomization;
  6. Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomization;
  7. Use of leflunomide within 6 months of randomization;
  8. Use of etanercept or anakinra within 4 weeks of randomization;
  9. Use of a B-cell depleting agent such as rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomization;
  10. 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;
  11. Currently taking cytochrome P450 inducers including St. John's wort, rifampicin, rifabutin, rifapentin, dexamethasone, phenytoin, carbamazapine, phenobarbitol, or troglitazone;
  12. Intra-articular, intravenous, or intramuscular corticosteroid injection within 4 weeks of randomization;
  13. 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;
  14. Evidence of tuberculosis (TB) based on chest X rays, tuberculin skin test, QuantiFERON®-TB Gold test, or T-SPOT®.
  15. Presence of Felty's syndrome, psoriatic arthritis, gout, or other auto-immune diseases;
  16. Major surgery (including joint surgery) within 12 weeks prior to randomization;
  17. The subject had an infection requiring antibiotic treatment within 4 weeks of randomization;
  18. Subject has any evidence of hepatic disease; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase, or bilirubin > 1.5 x the upper limit of normal;
  19. Subject has any evidence of renal impairment; serum creatinine > 1.5 x upper limit of normal or estimated Glomerular Filtration Rate (GFR) based on the Cockcroft-Gault equation < 30 mL/min;
  20. 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
  21. Participated in any clinical study of an investigational product including CCX354-C within 30 days or 5 times the half life of the agent, whichever is longer, prior to randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242917

  Show 41 Study Locations
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx, Inc.
  More Information

No publications provided

Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT01242917     History of Changes
Other Study ID Numbers: CL004_354, 2010-019964-36
Study First Received: November 15, 2010
Last Updated: February 8, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Romania: National Medicines Agency
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014