Condition category
Musculoskeletal Diseases
Date applied
30/11/2010
Date assigned
05/04/2011
Last edited
01/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul-Peter Tak

ORCID ID

Contact details

Division of Clinical Immunology and Rheumatology
Academic Medical Center
Meibergreef 9
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01242917

Protocol/serial number

CL004_354

Study information

Scientific title

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

Acronym

CARAT-2

Study hypothesis

That CCX354-C will be safe and well tolerabate by subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment.

Ethics approval

The Ethics Committee of the University Hospital and Medical School, Leige (Comite d'Ethique Hospitalo-Facultaire Universitaire de Leige [707]) approved on the 26th August 2010 (ref: 2010/112)

Study design

Multicentre double blind randomised placebo controlled parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Rheumatoid arthritis

Intervention

150 subjects with RA, partially responsive to methotrexate therapy will be randomised to one of the following treatment arms:
1. Placebo comparator: placebo tablet twice daily for 12 weeks + methotrexate
2. CCX354-C twice daily: 100 mg tablet twice daily for 12 weeks + methotrexate
3. CCX354-C once daily: 100 mg (2) tablets once daily for 12 weeks + methotrexate

To ensure patient safety, all patients will be followed for 28 days from the end of the intervention.

Intervention type

Drug

Phase

Phase II

Drug names

CCX354-C, methotrexate

Primary outcome measures

Subject incidence of adverse events at 12 weeks

Secondary outcome measures

1. Disease Activity Score 28 using C-reactive protein (DAS28-CRP)
2. American College of Rheumatology (ACR) response criteria

All outcomes will be assessed at the end of the intervention period (12 weeks).

Overall trial start date

14/09/2010

Overall trial end date

30/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult subjects, with active RA, with at least 8 swollen joints, and 8 tender joints
2. Serum C-reactive protein (CRP) above upper limit of normal
3. Must have been on stable dose methotrexate for less than or equal to 8 weeks prior to randomisation
4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
5. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Diagnosed with RA prior to 16 years of age
2. 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 randomisation
3. Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomisation
4. Use of leflunomide within 6 months of randomisation
5. Use of etanercept or anakinra within 4 weeks of randomisation
6. Use of a B-cell depleting agent such as rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomisation

Recruitment start date

14/09/2010

Recruitment end date

30/08/2011

Locations

Countries of recruitment

Belgium, Czech Republic, Germany, Hungary, Netherlands, Poland, Romania, Ukraine

Trial participating centre

Division of Clinical Immunology and Rheumatology
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

ChemoCentryx, Inc. (USA)

Sponsor details

850 Maude Avenue
Mountain View
CA
94043
United States of America
vmarchesin@chemocentryx.com

Sponsor type

Industry

Website

http://www.chemocentryx.com/

Funders

Funder type

Industry

Funder name

ChemoCentryx, Inc. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes