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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01242917
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : February 9, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: CCX-354-C Drug: Placebo Drug: CCX354-C Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Subject incidence of adverse events [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01242917

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Sponsors and Collaborators
Study Director: Pirow Bekker, MD, PhD ChemoCentryx, Inc.

Responsible Party: ChemoCentryx Identifier: NCT01242917     History of Changes
Other Study ID Numbers: CL004_354
2010-019964-36 ( EudraCT Number )
First Posted: November 17, 2010    Key Record Dates
Last Update Posted: February 9, 2012
Last Verified: February 2012

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