AzTrials
AzTrials

Rheumatoid ArthritisPhase 2MDX1100-04NCT01017367

Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)

A Phase 2 study testing MDX-1100 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 18 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to: 1. determine the American College of Rheumatology (ACR) 20 response rate at Day 85 in subjects with active rheumatoid arthritis(RA) administered MDX 1100 with methotrexate (MTX); and 2. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
MDX-1100
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
18 sitesin 2 countries
Study dates
Feb 2008to May 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must meet the ACR criteria for RA
  • Must have active RA, characterized by at least 6 out of 66 swollen joints and 6 out of 68 tender joints, and at least 2 of the following: a serum C-reactive protein level greater than the upper limit of normal, an erythrocyte sedimentation rate >= 28 mm per hour, or morning stiffness > 45 minutes
  • Seropositive for rheumatoid factor, as defined by a plasma rheumatoid factor level of at least 20 IU per milliliter and/or be seropositive for anti-cyclic citrullinated peptide antibody
  • Must be on MTX (10 to 25 mg weekly) for at least 6 months receiving a stable dose for 42 days before randomization and no anticipated change in MTX dose while on study
  • Low-dose corticosteroids and NSAIDs are permitted at study entry and must have been stable for at least 28 days before randomization
  • All other disease modifying non-biologic anti-rheumatic drugs (DMARDs) must have been discontinued at least 28 days prior to randomization except for leflunomide (discontinued at least 60 days before randomization). Etanercept (discontinued at least 28 days prior to randomization) and infliximab, adalimumab, and abatacept (discontinued at least 56 days prior to randomization)
Show all 16Show fewer
  • Screening laboratory values
  • Hemoglobin ≥ 8.5 g/dL
  • White blood cell (WBC) ≥ 3000/mm³
  • Neutrophils ≥ 1.5x10(9)/L
  • Platelets ≥ 125x10(9)/L
  • Serum creatinine < 2 mg/dL
  • Aspartate aminotransferase (AST) ≤ 2xULN
  • Alanine aminotransferase (ALT) ≤ 2xULN
  • Women must be postmenopausal (> 12 months without menses) or surgically sterile or using effective contraception for at least 4 weeks prior to the anticipated Visit 2 date and agree to continue contraception for the duration of their participation in the study
  • Sexually active male subjects must use a barrier method of contraception during the course of the study.

Who cannot join

  • Prior treatment with B cell depleting therapy
  • Any other monoclonal antibody or immunoglobulin-based fusion proteins ≤ 8 weeks prior to randomization
  • Any other experimental treatment ≤ 4 weeks prior to randomization
  • Primary or secondary immunodeficiency
  • Any other autoimmune disease other than RA (except concurrent Sjogren's syndrome or hypothyroidism)
  • Complications of RA including:
Show all 20Show fewer
  • Active rheumatoid vasculitis
  • Bed bound or wheelchair bound
  • Clinically significant pulmonary fibrosis
  • Felty's syndrome
  • Any history of malignancy, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ
  • Active major psychiatric disease
  • Evidence of acute or chronic infection
  • Clinically significant cardiac disease requiring medication, unstable angina, myocardial infarction within 6 months of randomization, or congestive heart failure
  • Arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities;
  • History of cerebrovascular disease requiring medication/treatment;
  • Concomitant anticoagulation therapy or a known bleeding disorder
  • Seizure disorder requiring active therapy
  • Known drug or alcohol abuse
  • Pregnant or nursing

Trial locations and contacts

18 sites in 2 countries.

18 sites in 2 countries

Romania9 sites

  • Brasov Clinical County Emergency Hospital Rheumatology Department

    Brasov, 500365

  • "Dr. Carol Davila" Central Military Emergency Clinical Hospital

    Bucharest, 010825

  • Sana Medical Center

    Bucharest, 011025

  • "Sf. Maria" Clinical Hospital, Department of Internal Medicine and Rheumatology

    Bucharest, 011172

  • "Sf. Pantelimon" Emergency Clinical Hospital

    Bucharest, 21659

  • Cluj Emergency County Clinical Hospital Rheumatology Department

    Cluj-Napoca, 400006

  • Rehabilitation Hospital, Rheumatology Department

    Iași, 700656

  • Targu-Mures County Clinical Hospital Rheumatology Department

    Târgu Mureş, 540136

  • SC Excentric Company SRL, Rheumatology Department

    Timișoara, 300449

Other trials in Romania

Ukraine9 sites

  • M. Gorky National Medical University

    Donetsk, 83003

  • V.K. Gusak Institute of Urgent & Reconstructive Surgery within the Academy of Medical Sciences of Ukraine, Hospital Therapy and Rehabilitation Clinic

    Donetsk, 83045

  • Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology and Functional Diagnostics, Clinical Facility: City Clinical Hospital #8

    Kharkiv, 61178

  • Kyiv City Oleksandrivska Clinical Hospital, Rheumatology Department #2

    Kyiv, 01601

  • O.O. Bogomolets National Medical University, Department of Internal Diseases Propedeutics #2, Clinical facility: City Clinical Hospital #3

    Kyiv, 02125

  • Danylo Halytsky Lviv National Medical University, Department of Clinical Immunology and Allergology, Clinical Facility: Lviv Regional Clinical Hospital, Rheumatology Department

    Lviv, 79010

  • Danylo Halytsky Lviv National Medical University, Department of Internal Diseases #2, Dermatology and Venerology within the Faculty of Continuing Education, Clinical facility: City Clinical Hospital #4, Rheumatology Department

    Lviv, 79014

  • Public Institution O.I. Minakov City Clinical Hospital #9, Rheumatology Department

    Odesa, 65026

  • Zaporizhya State Medical University, Department of Internal Diseases #2, Clinical facility: Medical and Sanitary Unit within the State-Owned Company "Radioprylad"

    Zaporizhya, 69118

Other trials in Ukraine

About this study

Official title: Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (RA)

The purpose of this study is to:

  1. determine the American College of Rheumatology (ACR) 20 response rate at Day 85 in subjects with active rheumatoid arthritis(RA) administered MDX 1100 with methotrexate (MTX); and
  2. determine the tolerability and safety of multiple doses of MDX-1100 in combination with MTX in subjects with active RA.
Read the detailed description

This Phase 2, double-blind, placebo-controlled, randomized, multi-dose, multicenter study of MDX 1100 (anti CXCL10 human monoclonal antibody) in combination with MTX in subjects with active RA. All subjects will continue to receive stable doses of MTX (10 to 25 mg weekly) during the study. Eligible subjects (n=70) will be randomized to receive either placebo (n=35) or MDX-1100 (n=35) at 10 mg/kg intravenously, every other week for a total of 6 doses. Concomitant treatment with stable doses of prednisolone (≤ 10 mg/d, or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDS) and analgesic drugs will be permitted during the study, however, the dose should not be changed until after the Day 85 assessment has been completed unless rescue therapy is required for significant worsening symptoms prior to Day 85. After Day 85, subjects will be followed until Day 141 only for safety and pharmacokinetics, and changes to baseline medications or addition of new medication will be permitted at the Investigator's discretion. Non-steroid anti-inflammatory drugs (NSAIDS) or analgesics should not be administered prior to disease activity assessments on study visit days.

Subjects withdrawn prior to Day 85 will be followed for safety for 70 days following their last dose of study drug.

Being tested
MDX-1100, Placebo
Keywords
RA, inflammatory joint disease
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • MDX-1100Drug

    Also called Anti CXCR4 Monocolonal anti-body, anti-IP-10

    MDX-1100 10 mg/kg i.v. over 60 minutes on days 1, 15, 29, 43, 57 and 71

  • PlaceboDrug

    Placebo

Study groups in NCT01017367
Study groupRoleWhat they receive
MDX-1100ExperimentalMDX-1100 10 mg/kg administered i.v. over 60 minutes on days 1, 15, 29, 43, 57, and 71
Receives: Drug: MDX-1100
PlaceboPlacebo comparatorPlacebo (saline) administered i.v. over 60 minutes on days 1, 15, 29, 43, 57, and 71
Receives: Drug: Placebo

What is being measured

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

  1. ACR 20 Response rate

    Measured: 85 days

Secondary outcomes (1)

  1. Safety and tolerability will be monitored by physical exam, laboratory tests, electrocardiograms, chest x-ray and adverse events experienced and reported by the patient

    Measured: 141 days

Timeline

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

  1. First posted20 Nov 2009 (estimated)
  2. Study startFeb 2008
  3. Primary completionJan 2009
  4. Study completionMay 2009

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01017367
Sponsor's protocol ID
MDX1100-04
Other IDs
IM129-003
Acronym
MDX1100-04
Status last verified
Apr 2010
First submitted
16 Nov 2009
Last updated
23 Apr 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Yellin M, Paliienko I, Balanescu A, Ter-Vartanian S, Tseluyko V, Xu LA, Tao X, Cardarelli PM, Leblanc H, Nichol G, Ancuta C, Chirieac R, Luo A. A phase II, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of MDX-1100, a fully human anti-CXCL10 monoclonal antibody, in combination with methotrexate in patients with rheumatoid arthritis. Arthritis Rheum. 2012 Jun;64(6):1730-9. doi: 10.1002/art.34330. Epub 2011 Dec 6.

    PubMed 22147649

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MDX-1100 in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 18 sites in 2 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 16 inclusion and 20 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 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Romania, Ukraine. 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?

ACR 20 Response rate (time frame: 85 days). 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 NCT01017367, 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 Apr 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
MDX1100-04 Clinical Trial NCT01017367 | AzTrials