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

NCT01242917 | Completed Phase 2 DMC

• 2 other identifiers: CL004_3542010-019964-36
• Study Type: interventional
• Target: 159
• Locations: 8 countries
• Sites: 41

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Subject incidence of adverse events

  12 weeks

Secondary Outcomes (1)

• The change from baseline to week 12 of Disease Activity Score for 28 Joints using C-reactive proteine (DAS28-CRP)

  12 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CCX354-C 100mg twice daily

EXPERIMENTAL

Drug: CCX354-C

CCX354-C 200mg once daily

EXPERIMENTAL

Drug: CCX-354-C

Interventions

CCX354-C DRUG

100mg film-coated tablets twice daily for 12 weeks + methotrexate

CCX354-C 100mg twice daily

Placebo DRUG

Placebo film-coated tablets twice daily for 12 weeks + methotrexate

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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
• Serum C-reactive protein (CRP) above 5 mg/L at screening;
• 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;
• If on hydroxychloroquine, must have been on a stable dose for ≥ 16 weeks prior to randomization;
• If taking non-steroidal anti-inflammatory drugs (NSAIDs), must have been on stable doses for ≥ 2 weeks before randomization;
• 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;
• 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 administration of study medication

You may not qualify if:

• 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;
• 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;
• 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 a B-cell depleting agent such as 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;
• Currently taking cytochrome P450 inducers including St. John's wort, rifampicin, rifabutin, rifapentin, dexamethasone, phenytoin, carbamazapine, phenobarbitol, or troglitazone;
• Intra-articular, intravenous, or intramuscular corticosteroid injection within 4 weeks of randomization;
• 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 (TB) based on chest X rays, tuberculin skin test, QuantiFERON®-TB Gold test, or T-SPOT®.
• Presence of Felty's syndrome, psoriatic arthritis, gout, or other auto-immune diseases;

Sponsors & Collaborators

• Amgen: lead

Study Sites (41)

Unknown Facility

Brussels, Belgium

Location

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Kortrijik, Belgium

Location

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Liège, Belgium

Location

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Brno, Czechia

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Bruntál, Czechia

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Hlučín, Czechia

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Ostrava-Trebovice, Czechia

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Prague, Czechia

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Uherské Hradiště, Czechia

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Zlín, Czechia

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Berlin, Germany

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Frankfurt, Germany

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Hanover, Germany

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Herne, Germany

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Leipzig, Germany

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Mainz, Germany

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Würzburg, Germany

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Balatonfüred, Hungary

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Békéscsaba, Hungary

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Budapest, Hungary

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Székesfehérvár, Hungary

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Veszprém, Hungary

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Amsterdam, Netherlands

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Chełm Śląski, Poland

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Elblag, Poland

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Grodzisk Mazowiecki, Poland

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Krakow, Poland

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Lublin, Poland

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Poznan, Poland

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Warsaw, Poland

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Żyrardów, Poland

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Bacau, Romania

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Baia Mare, Romania

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Brăila, Romania

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Bucharest, Romania

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Galati, Romania

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Saint Gheorghe, Covasna, Romania

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Târgovişte, Romania

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Donetsk, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 17, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

BE (3); PL (8); DE (7); HU (5); UA (3); CZ (7); NL (1); RO (7)