AzTrials
AzTrials

Rheumatoid ArthritisPhase 2NCT00292422

Dose-Escalating Study of BG9924 in Combination With Methotrexate in Active Rheumatoid Arthritis

A Phase 2 study testing BG9924 in people with Rheumatoid Arthritis, run by Biogen at 10 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

This Phase 2a study is designed to evaluate the safety and tolerability of multiple subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy with disease-modifying anti rheumatic drugs (DMARDs)… 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?
BG9924
How many people
50 participants
Where
10 sitesin 2 countries
Study dates
Nov 2005to May 2007
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

  • Must give written informed consent. If required by local law, candidates must also authorize the release and use of protected health information (PHI).
  • Male or female subjects aged 18 to 75 years old, inclusive, at the time informed consent is given.
  • Must have a diagnosis of RA Functional Class I-III according to the 1987 Revised American Rheumatism Association Criteria for the Classification of Rheumatoid Arthritis for at least 6 months prior to baseline.
  • Must have been treated with MTX (>=10 mg/week to <=25 mg/week) for at least 3 months immediately prior to enrollment. The dose of MTX must be stable for at least 4 weeks prior to Day 0.
  • Must have active disease at Screening defined as SJC >=5 (66 joint count) and TJC >=5 (68 joint count).
  • All DMARDs, other than MTX or hydroxychloroquine sulfate, must be withdrawn at least 4 weeks prior to Day 0 (8 weeks for infliximab, adalimumab, and leflunomide).
  • Male and female subjects of child-bearing potential must be willing to practice effective birth control for the duration of the study. Female subjects must be: (1) postmenopausal for at least 12 months, (2) surgically sterile, or (3) willing to use 2 documented forms of birth control (e.g., barrier and spermicide, intrauterine device and barrier or spermicide, or birth control pill and barrier or spermicide).
  • Subjects must be willing and able to complete all planned study procedures.

Who cannot join

  • Subjects with a history of a malignancy or carcinoma in situ (subjects with a history of excised or treated basal cell carcinoma are eligible to participate in this study).
  • Moles or lesions currently undiagnosed, but suspicious for malignancy.
  • Subjects with a history of clinically significant (as determined by the Investigator) cardiac, allergic, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal or hematologic insufficiency or major disease.
  • Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome is permitted.
  • Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months prior to Day 0.
  • History of recurrent significant infections.
Show all 37Show fewer
  • Primary or secondary immunodeficiency (history of or currently active).
  • History of tuberculosis or positive purified protein derivative (PPD; positive Mantoux test defined as ³10 mm of induration [size of raised bump, not redness]) test during the screening period. Subjects whose PPD induration is >=5 mm but <10 mm are eligible for the study if they have a negative chest X-ray during the screening period.
  • Fever (body temperature >38°C) or symptomatic viral infection or bacterial infection within 2 weeks prior to Day 0.
  • Receipt of live vaccine within 4 weeks prior to Day 0.
  • Clinically significant chest X-ray abnormality within 3 months prior to Screening.
  • Current or prior treatment with more than 1 anti-TNF agent (etanercept, infliximab, or adalimumab) or other approved or investigational biologic agent for the treatment of RA.
  • Previous treatment with an anti-a4 integrin antibody within the last 6 months.
  • Anti-TNF therapy with infliximab or adalimumab within 8 weeks or etanercept within 4 weeks prior to Day 0.
  • Treatment with another investigational drug within the 3 months prior to Day 0 or within 5 half-lives of the agent, which ever is longer.
  • If the subject has previously received cell-depleting therapies, relevant cell counts must have returned to normal.
  • Subjects will be excluded who meet any of the following criteria regarding treatment with concomitant therapy for RA:
  • Concomitant use of an oral steroid exceeding 10 mg/day of prednisone (or equivalent dose) or, if 10 mg/day or less, was not administered at a stable dose for at least 4 weeks prior to Day 0.
  • Concomitant use of an NSAID that was not administered at a stable dose for at least 2 weeks prior to Day 0.
  • Concomitant use of hydroxychloroquine sulfate at >400 mg/day or not administered at a stable dose for 4 weeks prior to Day 0.
  • Concomitant use of other anti-arthritic treatments, including approved or experimental oral or topical agents, within 4 weeks prior to Day 0.
  • Intra-articular corticosteroid injections within 4 weeks prior to Day 0.
  • Previous exposure to BG9924.
  • Subjects will be excluded who underwent any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement), within 12 weeks prior to baseline or who are planning such a procedure within 16 weeks after randomization.
  • Subjects with any laboratory test result at Screening considered clinically significant (as determined by the Investigator) or
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN) established by the central laboratory
  • Platelet count <150,000/μL
  • Hemoglobin <8.5 g/dL
  • Neutrophil count <1.5-10^3/μL
  • Positive for hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV; it is recognized that HIV testing may not be permitted at all sites).
  • Nursing mother, pregnant women and women who are planning to become pregnant while in the study.
  • Blood donation (1 unit or more) within 1 month prior to screening.
  • History of drug or alcohol abuse (as determined by the Investigator) within 1 year prior to Day 0.
  • Current enrollment in any other investigational drug study.
  • Previous participation in this study.
  • Subjects who are expected to be unavailable for the duration of the trial, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator/Sponsor for any other reason.
  • Other unspecified reasons that, in the opinion of the Investigator/Sponsor, make the subject unsuitable for enrollment.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Poland7 sites

  • Centrum Medyczne SpecjalistycznyGabinet Lekarski

    Bialystok, 15-337

  • Oddzial Reumatologii Wojewodzki Szpital

    Elblag, 82-300

  • Osrodek Badan Klinicznych

    Lublin, 20-022

  • Prakyta Lekarza Rodzinnego "Nasz Lekarz"

    Torun, 87-100

  • Klinika Chorob Tkanki Lacznej-Instytut Reumatologiczny

    Warsaw, 02-637

  • Klinika Reumatologii-Instytut Reumatologiczny

    Warsaw, 02-637

  • Centrum Leczenia Chorob Cywilizacyjnych

    Warsaw, 02-777

Other trials in Poland

United States3 sites

  • Fiechtner Research Inc.

    Lansing, Michigan, 48910

  • The Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Arthritis Consultants Inc.

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: A Randomized, Blinded, Placebo-Controlled, Multicenter, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BG9924 When Given in Combination With Methotrexate to Subjects With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to DMARD Therapy

This Phase 2a study is designed to evaluate the safety and tolerability of multiple subcutaneous (SC) doses of BG9924, administered in a cohort dose-escalation fashion, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to therapy with disease-modifying anti rheumatic drugs (DMARDs) and who may have undergone anti-TNF therapy. This study will assist with dose selection for further planned Phase 2 studies.

Being tested
BG9924
Keywords
Arthritis, Rheumatoid, Methotrexate, Antirheumatic Agents
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • BG9924Drug

What is being measured

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

  1. To evaluate the safety and tolerability of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to DMARD therapy

Secondary outcomes (2)

  1. To assess the pharmacokinetics and pharmacodynamics of multiple doses of BG9924 in this patient population

  2. To assess the preliminary efficacy of multiple doses of BG9924 in this patient population

Timeline

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

  1. First posted16 Feb 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionMay 2007
  4. Study completionMay 2007

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00292422
Sponsor's protocol ID
104-RA-201
Status last verified
Dec 2007
First submitted
15 Feb 2006
Last updated
31 Dec 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BG9924 in people with Rheumatoid Arthritis, run by Biogen at 10 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 8 inclusion and 37 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 31 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Poland, United States. 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. 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?

To evaluate the safety and tolerability of BG9924 when administered in combination with MTX to subjects with active RA who have had an inadequate response to DMARD therapy. 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 NCT00292422.

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 31 Dec 2007.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in