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Rheumatoid ArthritisPhase 4NCT01758198

Abatacept Post-marketing Clinical Study in Japan

A Phase 4 study testing Abatacept and Methotrexate in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 74 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 compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Abatacept and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
405 participants
Where
74 sitesJapan
Study dates
11 Apr 2013to 26 Dec 2016
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • MTX inadequate responder
  • Biologic Naïve
  • Functional class I, II or III
  • ≥6 swollen and ≥6 tender joints
  • C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
  • Anti-cyclic citrullinated peptide (CCP) antibody positive
  • Have erosion

Who cannot join

  • Any other rheumatic disease
  • Active angiitis on main organs excluding rheumatoid nodule

Trial locations and contacts

74 sites in 1 country.

74 sites in 1 country

Japan74 sites

  • Local Institution

    Asahi, 289-2511

  • Local Institution

    Fuchū, 183-8524

  • Local Institution

    Fujieda, Shizuoka, 426-8677

  • Local institution

    Fukuoka, 810-8563

  • Local Institution

    Fukuoka, 813-0017

  • Local institution

    Funabashi, 274-0053

  • Local Institution

    Hakodate, 040-8611

  • Local Institution

    Hiroshima, 734-8551

  • Local Institution

    Hitachi, 316-0015

  • Local institution

    Hokkaido, 078-8243

  • Local Institution

    Iizuka, 820-8505

  • Local Institution

    Izumisano, Osaka, 598-0048

  • Local Institution

    Kagoshima, 890-0067

  • Local Institution

    Kagoshima, 891-0133

  • Local Institution

    Kakogawa, Hyōgo, 675-8611

  • Local Institution

    Kamogawa, Chiba, 296-8602

  • Local Institution

    Kanazawa, 920-8616

  • Local Institution

    Kasama, 309-1793

  • Local Institution

    Kasamatsu-town, Gifu, 501-6061

  • Local Institution

    Katō, 673-1462

  • Local Institution

    Kitakyushu, 800-0031

  • Local Institution

    Kitakyushu, 800-0296

  • Local Institution

    Kitakyushu, 807-8556

  • Local Institution

    Kitamoto, 364-8501

  • Local institution

    Kobe, 650-0017

  • Local institution

    Kobe, 654-0047

  • Local Institution

    Kochi, 781-0112

  • Local Institution

    Kōshi, 861-1196

  • Local institution

    Kumamoto, 862-0976

  • Local Institution

    Kurashiki, Okayama-ken, 710-8602

  • Local Institution

    Matsumoto, 390-8601

  • Local Institution

    Nagano, 380-8582

  • Local Institution

    Nagaoka, 940-2085

  • Local Institution

    Nagasaki, 850-0832

  • Local Institution

    Nagoya, 460-0001

  • Local Institution

    Nagoya, 466-8560

  • Local Institution

    Narashino, 275-0006

  • Local Institution

    Narita, 286-0041

  • Local Institution

    Okayama, 700-8607

  • Local institution

    Ōme, 198-0042

  • Local institution

    Osaka, 545-8585

  • Local Institution

    Ōsaki, 989-6183

  • Local institution

    Sapporo, 001-0907

  • Local Institution

    Sapporo, 060-0001

  • Local Institution

    Sapporo, 060-8648

  • Local Institution

    Sapporo, 063-0811

  • Local Institution

    Sasebo, 857-1195

  • Local Institution

    Sayama, 350-1305

  • Local Institution

    Sendai, 980-6116

  • Local Institution

    Sendai, 982-0032

  • Local Institution

    Sendai, 983-8512

  • Local Institution

    Shimonoseki, Yamaguchi, 750-8520

  • Local Institution

    Shizuoka, 420-0821

  • Local Institution

    Takaoka, 933-0874

  • Local Institution

    Takasaki, 370-0053

  • Local institution

    Tokyo, 101-0062

  • Local Institution

    Tokyo, 104-8560

  • Local Institution

    Tokyo, 130-8575

  • Local Institution

    Tokyo, 160-8582

  • Local Institution

    Tokyo, 162-8543

  • Local Institution

    Tokyo, 162-8655

  • Local Institution

    Tokyo, 170-8476

  • Local Institution

    Tokyo, 173-8610

  • Local Institution

    Tokyo, 174-0071

  • Local Institution

    Tokyo, 179-0072

  • Local Institution

    Tomakomai, 053-0018

  • Local Institution

    Toyama, Toyama, 930-8550

  • Local Institution

    Toyama, 930-0138

  • Local Institution

    Toyama, 930-0194

  • Local Institution

    Utsunomiya, 321-0964

  • Local Institution

    Yokohama, Kanagawa, 245-8575

  • Local institution

    Yokohama, 231-8682

  • Local institution

    Yokohama, 236-0004

  • Local Institution

    Yotsukaidō, 284-0003

Other trials in Japan

About this study

Official title: A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.

Being tested
Abatacept, Placebo matching with Abatacept, Methotrexate
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • AbataceptBiological

    Also called BMS-188667 (Orencia)

  • Placebo matching with AbataceptDrug

  • MethotrexateDrug

Study groups in NCT01758198
Study groupRoleWhat they receive
Group 1: Abatacept + Methotrexate (MTX)ExperimentalAbatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Receives: Biological: Abatacept; Drug: Methotrexate
Group 2: Placebo matching with Abatacept + MethotrexatePlacebo comparatorPlacebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months Methotrexate ≥6 mg/week for 12 months
Receives: Drug: Placebo matching with Abatacept; Drug: Methotrexate

What is being measured

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

  1. American College of Rheumatology (ACR) 20% response rate

    Measured: 4 months (week 16)

  2. Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)

    Measured: Baseline (Day 1), 6 months (Week 24)

Secondary outcomes (5)

  1. Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)

    Measured: Baseline (Day 1), 4 months (Week 16)

  2. Non-progressors rate for the structural damage

    The non-progressors rate is defined as the proportion of subjects meeting the change from baseline in the TSS at 6 months less than or equal to the smallest detectable difference (SDD) and/or the smallest detectable change (SDC)

    Measured: Baseline (Day 1), 6 months (Week 24)

  3. ACR 50 response rates

    Measured: 4 months (Week16)

  4. ACR 70 response rates

    Measured: 4 months (Week16)

  5. Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities

    Measured: 12 months (Week52)

Timeline

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

  1. First posted1 Jan 2013 (estimated)
  2. Study start11 Apr 2013
  3. Primary completion26 Dec 2016
  4. Study completion26 Dec 2016

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01758198
Sponsor's protocol ID
IM101-338
Status last verified
May 2017
First submitted
19 Dec 2012
Last updated
15 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abatacept and Methotrexate in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 74 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 7 inclusion and 2 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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

American College of Rheumatology (ACR) 20% response rate (time frame: 4 months (week 16)). The study lists 2 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 NCT01758198.

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 15 May 2017.

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