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Arthritis, RheumatoidPhase 3NCT00732875

A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)

A Phase 3 study testing Infliximab + methotrexate (MTX) in people with Arthritis, Rheumatoid, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is extension part of the P04280 (placebo-controlled, double-blind, randomized study of chronic treatment with infliximab in approximately 140 patients, NCT00202852). This study will be conducted at 6 study centers in South Korea. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Infliximab + methotrexate (MTX)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
No sites listed yet
Study dates
Aug 2006to May 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients received placebo in main double-blind study (P04280, NCT00202852)
  • Patients received Infliximab-containing regimen showing clinical response at week 30 in main double-blind study (P04280)
  • [Main double-blind study (P04280, NCT00202852) inclusion criteria]
  • Diagnosis of rheumatoid arthritis (RA) according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed >6 months prior to screening.
  • Active disease at the time of screening and pre-infusion as defined by:
  • >=6 swollen joints
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  • >=6 tender joints and
  • 2 of the following:
  • morning stiffness >=45 min
  • erythrocyte sedimentation rate (ESR) >=28 mm/h
  • C-reactive protein (CRP) >=20 mg/L
  • Men and women, >=18 to <=75 years of age
  • Men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, intrauterine device (IUD), barrier method with spermicide, or surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion.
  • Must have been using oral or parenteral MTX for >3 months with no break(s) in treatment of >2 weeks total during this period. Patients must have been on a stable dose of >=12.5 mg/wk (maximum 20 mg/wk) for at >4 weeks prior to screening.
  • Must be on a stable dose of folic acid prophylaxis for >4 weeks prior to screening.
  • Patients using oral corticosteroids, must have been on a stable dose of <=10 mg/day for >4 weeks prior to screening. If currently not using corticosteroids the patient must have not received corticosteroids for >4 weeks prior to screening.
  • If using nonsteroidal anti-inflammatory drugs (NSAIDs), patients should have been on a stable dose for >4 weeks prior to screening.
  • The screening laboratory tests must meet the following criteria:
  • Hemoglobin >=5.3 mmol/L (>=8.5 g/dL), providing a low hemoglobin level is not due to nutritional deficiencies or due to diseases other than chronic RA
  • white blood cell (WBC) >=3.5 x 10^9/L (>=3.5 x 10^3/mm^3)
  • Neutrophils >=1.5 x 10^9/L (>=1.5 x 103/mm^3)
  • Platelets >=100 x 10^9/L (>=100 x 103/mm^3)
  • Serum transaminase <=2 times the upper limit of normal
  • Alkaline phosphatase levels <=2 times the upper limit of normal
  • Serum creatinine <=150 µmol/L (<=1.7 mg/dL)
  • Must be able to adhere to the study visit schedule and other protocol requirements.
  • Must be capable of giving informed consent and the consent must have been obtained prior to any study procedures including wash-out period.

Who cannot join

  • Exclusion criteria below of main double-blind study (P04280, NCT00202852)
  • [Main double-blind study (P04280, NCT00202852) exclusion criteria]
  • Pregnant women, nursing mothers, or a planned pregnancy within 1.5 years of enrollment.
  • Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
  • Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from infliximab, eg Lyme disease, or a rheumatic disease other than RA.
  • Use of disease modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.)
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  • Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening.
  • Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab)
  • Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months.
  • Treatment with any investigational drug within the previous 3 months.
  • Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents.
  • History of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions.
  • History of infected joint prosthesis within previous 5 years.
  • Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months.
  • Chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis.
  • Active tuberculosis (TB). Also excluded are patients who have evidence of latent TB (positive purified protein derivative [PPD] skin test or a history of latent TB) without adequate therapy for TB initiated prior to first infusion of study drug. Also excluded are patients with evidence of an old or latent TB infection without documented adequate therapy, if they will not be treated with antitubercular therapy during the trial. Patients with a current close contact with an individual with active TB will also be excluded. Additionally, patients who have completed treatment for active TB within the previous 2 years are now explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies. Also excluded are patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc, within the previous 6 months.
  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
  • History of lymphoproliferative disease including lymphoma or signs suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), or splenomegaly.
  • Any current known malignancy or history of malignancy within the previous 5 years, except for squamous or basal cell carcinoma of the skin that have been treated with no evidence of recurrence.
  • Patients with moderate or severe heart failure (New York Heart Association [NYHA] class III/IV).
  • Patients with pre-existing or recent onset of central nervous system demyelinating disorders.
  • Known recent substance abuse (drug or alcohol).
  • Patients in whom multiple venipunctures are not feasible due to poor tolerability or lack of easy access.
  • Have a known infection with HIV or known active hepatitis B/C infection (including associated chronic active hepatitis).

About this study

Official title: A Placebo-controlled, Double-blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment (Open-label Extension Part)

This trial is extension part of the P04280 (placebo-controlled, double-blind, randomized study of chronic treatment with infliximab in approximately 140 patients, NCT00202852). This study will be conducted at 6 study centers in South Korea. After completion of the last follow-up visit at Week 30 and code break in main double-blind trial, subjects randomized to the placebo group and those who were treated with an infliximab-containing regimen who maintained clinical response at the time of study completion will be provided with open-label infliximab for treatment of their conditions and additional safety data will be collected.

Being tested
Infliximab + methotrexate (MTX)
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infliximab + methotrexate (MTX)Biological

    Also called Remicade, SCH 215596

    Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)

Study groups in NCT00732875
Study groupRoleWhat they receive
Open Label Infliximab + MethotrexateExperimentalOpen label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
Receives: Biological: Infliximab + methotrexate (MTX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Experiencing Any Adverse Event

    Measured: throughout entire study (61 +/- 28.9 weeks on average)

  2. Number of Subjects Experiencing Serious Adverse Event

    Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.

    Measured: throughout entire study (61 +/- 28.9 weeks on average)

  3. Number of Subjects Experiencing Any Infection

    Measured: throughout entire study (61 +/- 28.9 weeks on average)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2008 (estimated)
  2. Study startAug 2006
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00732875
Sponsor's protocol ID
P05645
Status last verified
Mar 2017
First submitted
8 Aug 2008
Last updated
13 Apr 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Kim J, Ryu H, Yoo DH, Park SH, Song GG, Park W, Cho CS, Song YW. A clinical trial and extension study of infliximab in Korean patients with active rheumatoid arthritis despite methotrexate treatment. J Korean Med Sci. 2013 Dec;28(12):1716-22. doi: 10.3346/jkms.2013.28.12.1716. Epub 2013 Nov 26.

    PubMed 24339699

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infliximab + methotrexate (MTX) in people with Arthritis, Rheumatoid, run by Merck Sharp & Dohme LLC.

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 27 inclusion and 24 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects Experiencing Any Adverse Event (time frame: throughout entire study (61 +/- 28.9 weeks on average)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00732875, which also lists 1 linked publication.

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 13 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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