Rheumatoid ArthritisPhase 2CARAT-2NCT01242917
A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy
A Phase 2 study testing CCX-354-C and CCX354-C in people with Rheumatoid Arthritis, run by Amgen at 41 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- CCX-354-C and CCX354-C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 41 sitesin 8 countries
- Study dates
- Sep 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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;
- Major surgery (including joint surgery) within 12 weeks prior to randomization;
- The subject had an infection requiring antibiotic treatment within 4 weeks of randomization;
- 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;
- 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;
- 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
- 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
Trial locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
Poland8 sites
Study site
Chełm Śląski
Study site
Elblag
Study site
Grodzisk Mazowiecki
Study site
Krakow
Study site
Lublin
Study site
Poznan
Study site
Warsaw
Study site
Żyrardów
Czechia7 sites
Study site
Brno
Study site
Bruntál
Study site
Hlučín
Study site
Ostrava-Trebovice
Study site
Prague
Study site
Uherské Hradiště
Study site
Zlín
Germany7 sites
Study site
Berlin
Study site
Frankfurt
Study site
Hanover
Study site
Herne
Study site
Leipzig
Study site
Mainz
Study site
Würzburg
Romania7 sites
Study site
Bacau
Study site
Baia Mare
Study site
Brăila
Study site
Bucharest
Study site
Galati
Study site
Saint Gheorghe, Covasna
Study site
Targoviste
Hungary5 sites
Study site
Balatonfüred
Study site
Békéscsaba
Study site
Budapest
Study site
Székesfehérvár
Study site
Veszprém
About this study
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
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.
Read the detailed description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CCX-354-C, Placebo, CCX354-C
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCX-354-CDrug
200mg film-coated tablets once daily for 12 weeks + Methotrexate
PlaceboDrug
Placebo film-coated tablets twice daily for 12 weeks + methotrexate
CCX354-CDrug
100mg film-coated tablets twice daily for 12 weeks + methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CCX354-C 100mg twice daily | Experimental | Not described Receives: Drug: CCX354-C |
| CCX354-C 200mg once daily | Experimental | Not described Receives: Drug: CCX-354-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of adverse events
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242917
- Sponsor's protocol ID
- CL004_354
- Other IDs
- 2010-019964-36
- Acronym
- CARAT-2
- Status last verified
- Mar 2025
- First submitted
- 15 Nov 2010
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01242917
- Acronym / sponsor ID
- CARAT-2 / CL004_354
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CCX354-C 100mg twice daily | Experimental | Drug: CCX354-C |
| CCX354-C 200mg once daily | Experimental | Drug: CCX-354-C |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCX-354-C200mg film-coated tablets once daily for 12 weeks + Methotrexate | Drug | CCX354-C 200mg once daily |
| PlaceboPlacebo film-coated tablets twice daily for 12 weeks + methotrexate | Drug | Placebo |
| CCX354-C100mg film-coated tablets twice daily for 12 weeks + methotrexate | Drug | CCX354-C 100mg twice daily |
Primary outcome
Subject incidence of adverse events
Time frame: 12 weeks
1 secondary outcome
The change from baseline to week 12 of Disease Activity Score for 28 Joints using C-reactive proteine (DAS28-CRP)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CCX-354-C and CCX354-C in people with Rheumatoid Arthritis, run by Amgen at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Poland, Czechia, Germany, Romania, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject incidence of adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.