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Arthritis, RheumatoidPhase 2NCT00281294

A Phase 2 Study to Evaluate the Safety, Tolerability, and Activity of Fontolizumab in Subjects With Active Rheumatoid Arthritis

A Phase 2 study testing Fontolizumab in people with Arthritis, Rheumatoid, run by PDL BioPharma, Inc. at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Week 14 (Stage A of study). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Fontolizumab
How many people
40 participants
Where
9 sitesUnited States
Study dates
Dec 2005to Dec 2006
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

  • Male or female, at least 18 years of age
  • A diagnosis of RA according to ACR criteria (Appendix D, American College of Rheumatology Clinical Classification Criteria for Rheumatoid Arthritis)
  • RA functional class I, II, or III (Appendix E, ACR Revised Criteria for Classification of Functional Status in Rheumatoid Arthritis ) for at least 6 months
  • Active RA with ≥ 6 tender joints and ≥ 6 swollen joints within one week of dosing or on Day 0, before dosing
  • Serum CRP ≥ 1.0 mg/dL (10 mg/L) or ≥ 45 minutes of morning stiffness
  • On stable doses for at least 30 days before receiving study drug of at least one, but not more than two, of the following disease-modifying antirheumatic drugs (DMARDs): hydroxychloroquine, leflunomide, methotrexate (leflunomide-methotrexate combination is unacceptable), or sulfasalazine. If being treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose prednisone (≤ 10 mg/day), must be on stable regimen for at least 14 days before receiving study drug
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  • Women of childbearing potential with a negative serum pregnancy test at screening
  • Subjects with reproductive potential agree to use a double-barrier method of contraception during the study and for 3 months after receiving last dose of study drug
  • Must provide a signed and dated informed consent and an authorization to use protected health information, have the ability to understand the study requirements, and comply with study procedures, including required study visits

Who cannot join

  • Significant involvement of secondary RA (eg, Felty's syndrome, pulmonary fibrosis, Sjogren's syndrome, vasculitis (keratoconjunctivitis sicca is not exclusionary)
  • Received a live vaccine within 30 days of receiving fontolizumab
  • Received an investigational agent within 30 days or five half-lives of the agent, whichever is longer, of receiving fontolizumab
  • Received a corticosteroid injection into any joint, or has been treated with > 10 mg/day of a corticosteroid within 30 days of receiving fontolizumab
  • Received etanercept or anakinra within 30 days of receiving fontolizumab
  • Received gold salts, infliximab, or adalimumab within 60 days of receiving fontolizumab
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  • Received IV gamma-globulin or Prosorba column therapy within 90 days of receiving fontolizumab
  • Received rituximab or cyclophosphamide within 6 months of receiving fontolizumab
  • Failed B cell recovery after exposure to rituximab
  • History of hypersensitivity to glycine, histidine, or Polysorbate 80
  • Pregnant women or nursing mothers
  • Malignancy within 5 years (excluding basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ)
  • Known chronic viral infections with HIV, hepatitis B, or hepatitis C
  • Clinical, PPD, or clear radiographic evidence of prior TB
  • Infection requiring hospitalization or parenteral medication, such as an antibiotic, antiviral, antifungal, or antiparasitic agent, within 90 days of receiving fontolizumab
  • History of inflammatory joint disease (eg, gout, Lyme disease, psoriatic arthritis, reactive arthritis, seronegative spondyloarthropathy) or chronic inflammatory diseases (eg, inflammatory bowel disease, inflammatory myopathy, multiple sclerosis, overlap syndrome, scleroderma, systemic lupus erythematosus) other than RA
  • Clinically significant unstable or poorly controlled acute or chronic diseases, such as myocardial infarction within 6 months, unstable angina, poorly controlled diabetes or hypertension
  • ALT > 1.5 × the upper limit of normal; AST > 1.5 × the upper limit of normal; creatinine 1.5 × the upper limit of normal; absolute neutrophil count (ANC) < 1000/mm3; platelet count < 50,000/mm3
  • History of any other medical disease, laboratory abnormalities, or psychological conditions that would make the subject (based upon the principal investigator's judgment) unsuitable for study enrollment
  • Current abuse of alcohol or drugs (based upon investigator's assessment)
  • Major surgery within 3 months prior to or planned elective surgery during or within 3 months after last dose of study drug

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • The Center for Rheumatology

    Albany, New York, 12206

  • Rheumatology Associates Clinical Research

    Chicago, Illinois, 60612

  • Coeur d Alene Arthritis Clinic

    Coeur d'Alene, Idaho, 83814

  • Denver Arthritis Clinic

    Denver, Colorado, 80230

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Justus J. Fiechtner MD PC

    Lansing, Michigan, 48910-8595

  • Wallace Rheumatic Study Center

    Los Angeles, California, 90048

  • Stanford University Medical Center-Div. of Rheumatology

    Palo Alto, California, 94304

  • Benaroya Research Institute at Virginia Mason

    Seattle, Washington, 98101

Other trials in United States

About this study

To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Week 14 (Stage A of study).

Read the detailed description

To evaluate the efficacy of fontolizumab in subjects with active rheumatoid arthritis as determined by a 50% improvement of an American College of Rheumatology criteria (ACR50) response at Week 14 (Stage A of study).

Stage B of this trial is Double blind.

Being tested
Fontolizumab
Keywords
Arthritis, Rheumatoid
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • FontolizumabDrug

What is being measured

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

  1. -Proportion of subjects achieving an American College of Rheumatology response (ACR50) at Week 14 (Stage A).

Secondary outcomes (12)

  1. Proportion of subjects achieving ACR20, ACR50, and ACR70 (Stages A and B)

  2. Change from baseline in serum CRP values (Stages A and B)

  3. Percent improvement in individual ACR core outcome measures (Stages A and B)

  4. Change from baseline in DAS28-CRP and ACR-N (Stages A and B)

  5. ACR-N at each dosing day and at 1 and 3 months after the last dose of study drug (Stages A and B)

  6. Number and proportion of subjects experiencing a disease flare-up since Week 14 (Stage B)

  7. Time to disease flare since Week 14 (Stage B)

  8. Assess the safety and tolerability of fontolizumab throughout the study by collection of the following:

  9. Adverse events and SAEs up to 84 days after last dose of study drug; and, opportunistic or medically significant infections, malignancies, and onset of autoimmune diseases up to 6 months after last dose of study drug

  10. Clinical laboratory measurements (hematology, serum chemistry) up to 84 days after last dose of study drug

  11. Evaluation of pharmacokinetics (PK) up to 6 months after last dose of study drug (Stages A and B)

  12. Evaluation of immunogenicity up to 6 months after last dose of study drug (Stages A and B)

Timeline

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

  1. First posted24 Jan 2006 (estimated)
  2. Study startDec 2005
  3. Study completionDec 2006

Why it stopped: Terminated early because the first phase didn't meet the endpoint.

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
Single group
Masking
None (open label)
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281294
Sponsor's protocol ID
ZAF-711
Status last verified
Aug 2008
First submitted
20 Jan 2006
Last updated
5 Aug 2008
Results posted
No

Publications

  • Wilson JA, Prow NA, Schroder WA, Ellis JJ, Cumming HE, Gearing LJ, Poo YS, Taylor A, Hertzog PJ, Di Giallonardo F, Hueston L, Le Grand R, Tang B, Le TT, Gardner J, Mahalingam S, Roques P, Bird PI, Suhrbier A. RNA-Seq analysis of chikungunya virus infection and identification of granzyme A as a major promoter of arthritic inflammation. PLoS Pathog. 2017 Feb 16;13(2):e1006155. doi: 10.1371/journal.ppat.1006155. eCollection 2017 Feb.

    PubMed 28207896

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fontolizumab in people with Arthritis, Rheumatoid, run by PDL BioPharma, Inc. at 9 sites in United States.

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 9 inclusion and 21 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: stopped early, as of the sponsor's last update on 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in 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 was stopped early (reason given: Terminated early because the first phase didn't meet the endpoint.). Results are not available in the source record.

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?

-Proportion of subjects achieving an American College of Rheumatology response (ACR50) at Week 14 (Stage A).. 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 NCT00281294, 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 5 Aug 2008.

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