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Rheumatoid ArthritisPhase 2NCT00326339

Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)

A Phase 2 study testing R788 in people with Rheumatoid Arthritis, run by Rigel Pharmaceuticals at 38 sites in 2 countries.

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

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and 150 mg bid). 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?
R788
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
189 participants
Where
38 sitesin 2 countries
Study dates
Aug 2006to Dec 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

  • Patients must give written informed consent by signing an IRB-approved Informed Consent Form (ICF) prior to admission to this study.
  • Males and females, 18 to 75 years of age, with active RA for at least 12 months (functional class I-III, e.g., not bed or wheelchair-bound) who have been receiving weekly doses of methotrexate (10-25 mg/week) for a minimum of 180 days, and who have been receiving a stable MTX dose of at least 15 mg without any change in route or change in folic acid supplementation for at least 30 days.
  • Active RA is defined as the presence of (a)6 swollen joints (28 joint count); AND (b)6 tender joints (28 joint count); AND (c) CRP level > ULN for the central reference laboratory.
  • Patient may receive up to 10 mg per day of oral prednisone or steroid equivalent, NSAID therapy, hydroxychloroquine, chloroquine, minocycline, sulfasalazine, and doxycycline. The dose(s) must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements.
  • Females of childbearing potential must be fully informed of the potential for methotrexate and R788 to adversely affect the fetus and must agree to use adequate (2 methods) contraception during the study. These patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
  • The patient is in otherwise good health as determined by the Investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period, including the absence of clinically significant findings, such as HIV, HBV or HCV, interstitial pneumonitis or active pulmonary infection, on chest X-ray taken within 6 months prior to screening and a negative TB skin test, or abnormal liver function defined as known ALT >1.2xULN within the past 90 days.
  • In the investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol.

Who cannot join

  • The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study (these will be included in an exclusion log).
  • The patient has a history of substance abuse, drug addiction or alcoholism.
  • The patient is unable to abstain from alcohol during the study.
  • The patient has a recent (past 5 years) history of, or treatment for, a malignancy other than basal skin cancer.
  • The patient has received any investigational medication within 30 days prior to admission to the study.
  • Any patient who has received any of the following treatments must abide by the indicated washout period:
Show all 15Show fewer
  • oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to Day 1 dosing
  • cyclosporine, abatacept, etanercept, infliximab or adalimumab require a 60 day washout period prior to Day 1 dosing
  • leflunomide requires a 60 day washout period prior to screening, unless the patient has undergone cholestyramine washout at least 30 days prior to Day 1 dosing
  • cyclophosphamide requires a 180 day washout period prior to Day 1 dosing
  • Rituxan requires a 180 day washout period and normal CD19 count prior to Day 1 dosing
  • parenteral or intra-articular corticosteroids require a 30 day washout period prior to Day 1 dosing
  • Patients with the following laboratory abnormalities: ALT > 1.2X ULN, creatinine > ULN, a neutrophil count < 2,500/mm3 or lymphocyte count < 800/mm3, Hgb < 10 g/dL, platelet count < 125,000/mm3 are excluded.
  • Patients should not use CYP3A4 inhibitors from within 3 days of randomization until the end of study. R406 is metabolized by CYP3A4, and ketoconazole increases the R406 AUC of a dose of R788 by approximately 2 fold.
  • Patients should not use CYP3A4 inducers from within 3 days of randomization until the end of the study. Although glucocorticoids are inducers, a stable dose of no more than 10 mg/day is allowed.

Trial locations and contacts

38 sites in 2 countries.

38 sites in 2 countries

United States27 sites

  • Austin Rheumatology Research

    Austin, Texas, 78705

  • East Penn Rheumatology Associates

    Bethlehem, Pennsylvania, 18015

  • Michigan Arthritis Research Center

    Brighton, Michigan, 48116

  • Low Country Rheumatology

    Charleston, South Carolina, 29406

  • Center for Arth. & Rheum. Disease, PC

    Chesapeake, Virginia, 23320

  • Coeur d'Alene Arthritis Clinical Trials

    Coeur d'Alene, Idaho, 83814-2644

  • Altoona Ctr. for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Research Across America

    El Paso, Texas, 79902

  • Phase III Clinical Research

    Fall River, Massachusetts, 02720

  • Arthritis Clinic

    Jackson, Tennessee, 38305

  • Clinical Research Division

    Mayfield Village, Ohio, 44143

  • SCRI

    Memphis, Tennessee, 38115

  • DMI research

    Ocala, Florida, 34471

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Westroad Medical Group

    Omaha, Nebraska, 68114

  • Arthritis & Osteoporosis Treatment Center

    Orange Park, Florida, 32073

  • Arthritis Associates Inc.

    Orlando, Florida, 32804

  • Arthritis Research of Florida, Inc.

    Palm Harbor, Florida, 34684

  • Arthritis Research of Florida

    Palm Harbor, Florida, 34684

  • NC Arthritis & Allergy Care Center

    Raleigh, North Carolina, 27609

  • Pacific Arthritis Center Medical Group

    Santa Maria, California, 93455

  • Lovelace Scientific Resources

    Sarasota, Florida, 34233

  • MMG Clinical Research

    South Bend, Indiana, 46601

  • The Center for Arthritis and Rheumatic Diseas

    South Miami, Florida, 33143

  • The Arthritis Center

    Springfield, Illinois, 62704

  • Clinical Research Center of Reading LLP

    West Reading, Pennsylvania, 19611

Other trials in United States

Mexico11 sites

  • Hospital Civil de Guadalajara "Fray Antonio Alcalde"

    Guadalajara, JA, 44280

  • Hospital Civil de Guadalajara "Dr. Juan I. Menchaca"

    Guadalajara, JA, 44340

  • Hospital Aranda de la Parra

    León, GT, 37000

  • Centro Médico del Instituto de Seguridad Social del Estado de Mexico y Municipios (CMISSEMYM)

    Metepec, MX, 52170

  • Clinica para el Diagnostico y Tratamiento de las Enfermedades Reumaticas, S.C.

    Mexico City, Mexico City, 06700,

  • Arke Estudios Clinicos, S.A. de C.V.

    Mexico City, Mexico City, 06700

  • Hospital General de Mexico

    Mexico City, Mexico City, 06726

  • Centro Médico DALINDE

    Mexico City, Mexico City, 06760

  • Hospital Regional "1° de Octubre", ISSSTE

    Mexico City, Mexico City, 07760

  • Facultad de Medicina y Hospital Universitario "Dr. Jose E. Gonzalez" de la Universidad Autonoma de Nuevo Leon

    Monterrey, Nuevo León, 64020

  • Hospital Central "Dr. Ignacio Morones Prieto"

    San Luis Potosí City, SL, 78240

Other trials in Mexico

About this study

Official title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and 150 mg bid). Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12 months and who have been receiving a weekly methotrexate (MTX) dose for a minimum of 6 months will be enrolled into the study.

Read the detailed description

The primary objective of this study is to assess the preliminary efficacy of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks The secondary objectives of this study are to assess the safety of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks, and to assess the general clinical and laboratory safety evaluations throughout the study.

Being tested
R788, Placebo
Keywords
R935788, Rheumatoid Arthritis, Syk Kinase
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • R788Drug

    Also called tamatinib fosdium

    R788 50 mg, 100 mg, or 150 mg PO bid

  • PlaceboDrug

    Placebo PO bid

Study groups in NCT00326339
Study groupRoleWhat they receive
1ExperimentalR788 50 mg PO bid
Receives: Drug: R788
2ExperimentalR788 100 mg PO bid
Receives: Drug: R788
3ExperimentalR788 150 mg PO bid
Receives: Drug: R788
4Placebo comparatorPlacebo PO bid
Receives: Drug: Placebo

What is being measured

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

  1. The Primary Efficacy parameter is ACR20 response rate at 3 months post dosing.

    Measured: 12 weeks

Secondary outcomes (12)

  1. ACR 20/50 responses over time

    Measured: 12 weeks

  2. Disease Activity Score (DAS) at baseline and endpoint

    Measured: 12 Weeks

  3. Mean changes (SDs) from baseline in Swollen Joint Count (28 joint count)

    Measured: 12 Weeks

  4. Mean changes (SDs) from baseline in Tender Joint Count (28 joint count)

    Measured: 12 Weeks

  5. Mean changes (SDs) from baseline in Physician global assessment of disease activity by visual analog scale (VAS)

    Measured: 12 Weeks

  6. Mean changes (SDs) from baseline in Patient global assessment of disease activity by VAS

    Measured: 12 Weeks

  7. Mean changes (SDs) from baseline in Patient assessment of pain by VAS

    Measured: 12 Weeks

  8. Mean changes (SDs) from baseline in HAQ-DI

    Measured: 12 Weeks

  9. Mean changes (SDs) from baseline in CRP

    Measured: 12 Weeks

  10. The frequency and severity of Liver Function Test abnormalities, especially ALT and alkaline phosphatase

    Measured: 12 Weeks

  11. The frequency and severity of hematopoietic cytopenias, principally effects on neutrophil, erythrocyte, and lymphocyte counts

    Measured: 12 Weeks

  12. The frequency and severity of clinically significant adverse events, especially skin rash, postural dizziness, and alterations in blood pressure and other relevant clinical outcomes

    Measured: 12 Weeks

Timeline

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

  1. First posted16 May 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionOct 2007
  4. Study completionDec 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
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00326339
Sponsor's protocol ID
C-935788-006
Status last verified
Mar 2008
First submitted
12 May 2006
Last updated
20 Apr 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing R788 in people with Rheumatoid Arthritis, run by Rigel Pharmaceuticals at 38 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 7 inclusion and 15 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 20 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Mexico. 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?

The Primary Efficacy parameter is ACR20 response rate at 3 months post dosing. (time frame: 12 weeks). 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 NCT00326339.

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 20 Apr 2009.

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