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Rheumatoid ArthritisPhase 3NCT00727987

A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase 3 study testing CNTO 148 and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Janssen Pharmaceutical K.K. at 65 sites in Japan.

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

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab. Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
CNTO 148 and Methotrexate (MTX)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
269 participants
Where
65 sitesJapan
Study dates
May 2008to Dec 2011
Phase
Phase 3
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 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)
  • Patients in whom MTX therapy (>= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration
  • Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration.

Who cannot join

  • Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab
  • Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc
  • Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

Japan65 sites

  • Study site

    Asahi

  • Study site

    Asahikawa

  • Study site

    Azumino

  • Study site

    Chiba

  • Study site

    Fukui

  • Study site

    Fukuoka

  • Study site

    Fukushima

  • Study site

    Gifu

  • Study site

    Goshogawara

  • Study site

    Hachiōji

  • Study site

    Hamamatsu

  • Study site

    Higashi-Hiroshima

  • Study site

    Hiki

  • Study site

    Hiroshima

  • Study site

    Hitachi

  • Study site

    Iruma

  • Study site

    Izumisano

  • Study site

    Izumo

  • Study site

    Kamakura

  • Study site

    Katō

  • Study site

    Kawachi-Nagano

  • Study site

    Kawagoe

  • Study site

    Kawasaki

  • Study site

    Kita-Gun

  • Study site

    Kitakyushu

  • Study site

    Kitamoto

  • Study site

    Kobe

  • Study site

    Kumamoto

  • Study site

    Kyoto

  • Study site

    Matsue

  • Study site

    Matsumoto

  • Study site

    Matsuyama

  • Study site

    Nagano

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Narashino

  • Study site

    Nishinomiya

  • Study site

    Ohta-Ku

  • Study site

    Ōita

  • Study site

    Osaka

  • Study site

    Ōsaki

  • Study site

    Sagamihara

  • Study site

    Saitama

  • Study site

    Sapporo

  • Study site

    Sasebo

  • Study site

    Sendai

  • Study site

    Shimotsuga

  • Study site

    Shimotsuke

  • Study site

    Shinjuku

  • Study site

    Shinjuku-Ku

  • Study site

    Shizuoka

  • Study site

    Suita

  • Study site

    Tokorozawa

  • Study site

    Tokushima

  • Study site

    Tokyo

  • Study site

    Toshima-Ku

  • Study site

    Toyama

  • Study site

    Toyoake

  • Study site

    Toyohashi

  • Study site

    Tsu

  • Study site

    Tsukuba

  • Study site

    Tsukubo

  • Study site

    Ube

  • Study site

    Yokohama

  • Study site

    Yufu

Other trials in Japan

About this study

Official title: A Study of Golimumab (CNTO 148) Administered in Combination With Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

Read the detailed description

This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152

Being tested
CNTO 148, Placebo, Methotrexate (MTX)
Keywords
Rheumatoid arthritis, Fully Human anti-TNFa monoclonal antibody, CNTO148, Golimumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • CNTO 148Drug

    Also called Golimumab

    50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152.

  • PlaceboDrug

    Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24.

  • Methotrexate (MTX)Drug

    6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52.

Study groups in NCT00727987
Study groupRoleWhat they receive
CNTO 148 50 mg + methotrexateExperimentalNot described
Receives: Drug: CNTO 148; Drug: Methotrexate (MTX)
CNTO 148 100 mg + methotrexateExperimentalNot described
Receives: Drug: Methotrexate (MTX)
Placebo + methotrexatePlacebo comparatorNot described
Receives: Drug: Placebo; Drug: Methotrexate (MTX)

What is being measured

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

  1. ACR 20% response

    Measured: Week 14

Secondary outcomes (1)

  1. ACR 50% response, ACR 70% response, ACR 90% response, Changes from the pretreatment values in the DAS (Disease Activity Score) 28, and the HAQ (Health assessment questionnaire)

    Measured: Week 14

Timeline

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

  1. First posted5 Aug 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2011
  4. Study completionDec 2011

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00727987
Sponsor's protocol ID
CR015340
Other IDs
JNS012-JPN-03
Status last verified
May 2013
First submitted
31 Jul 2008
Last updated
23 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Tanaka Y, Harigai M, Takeuchi T, Yamanaka H, Ishiguro N, Yamamoto K, Miyasaka N, Koike T, Kanazawa M, Oba T, Yoshinari T, Baker D; GO-FORTH Study Group. Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study. Ann Rheum Dis. 2012 Jun;71(6):817-24. doi: 10.1136/ard.2011.200317. Epub 2011 Nov 25.

    PubMed 22121129

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CNTO 148 and Methotrexate (MTX) in people with Rheumatoid Arthritis, run by Janssen Pharmaceutical K.K. at 65 sites in Japan.

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 3 inclusion and 3 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 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Japan. 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 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?

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?

ACR 20% response (time frame: Week 14). 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 NCT00727987, 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 23 May 2013.

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