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Rheumatoid ArthritisPhase 2NCT00425321

Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

A Phase 2 study testing RWJ-445380 100 mg, RWJ-445380 200 mg and RWJ-445380 300 mg in people with Rheumatoid Arthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 42 sites in 7 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

The primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy. 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?
RWJ-445380 100 mg, RWJ-445380 200 mg and RWJ-445380 300 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
259 participants
Where
42 sitesin 7 countries
Study dates
Dec 2006to Jan 2008
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

  • Patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints
  • methotrexate treatment for 6 months
  • at least 10mg/wk and stable dose for at least 8 weeks
  • negative TB screening

Who cannot join

  • Use of other disease-modifying anti-rheumatic drugs (DMARDs) (other than Methotrexate MTX)
  • previous use of more than 1 anti-TNF (tumor necrosis factor) agent
  • previous use of cytotoxics, p38 MAPkinase inhibitor, anti-CD4 antibody
  • receipt of live vaccine within 1 month of study drug
  • serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection
  • other clinically significant disease of other organ system

Trial locations and contacts

42 sites in 7 countries.

42 sites in 7 countries

United States13 sites

  • Study site

    Austin, Texas

  • Study site

    Birmingham, Alabama

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Fair Oaks, California

  • Study site

    Frederick, Maryland

  • Study site

    Huntsville, Alabama

  • Study site

    Morton Grove, Illinois

  • Study site

    Nashville, Tennessee

  • Study site

    Sarasota, Florida

  • Study site

    Springfield, Illinois

  • Study site

    Tucson, Arizona

  • Study site

    Waterbury, Connecticut

  • Study site

    Whittier, California

Other trials in United States

Germany7 sites

  • Study site

    Bad Abbach

  • Study site

    Bad Nauheim

  • Study site

    Dresden

  • Study site

    Essen

  • Study site

    Frankfurt

  • Study site

    Herne

  • Study site

    Leipzig

Other trials in Germany

Poland7 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Krakow

  • Study site

    Lublin

  • Study site

    Poznan

  • Study site

    Szczecin

  • Study site

    Warsaw

Other trials in Poland

Czechia5 sites

  • Study site

    Brno

  • Study site

    Plzeò 1

  • Study site

    Prague

  • Study site

    Uherské Hradiště

  • Study site

    Zlín

Other trials in Czechia

Mexico4 sites

  • Study site

    Guadalajara

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    San Luis Potosí City

Other trials in Mexico

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Federal

  • Study site

    Luján

Other trials in Argentina

Brazil3 sites

  • Study site

    Curitiba

  • Study site

    Porto Alegre

  • Study site

    São Paulo

Other trials in Brazil

About this study

Official title: A Phase IIa Multicenter, Randomized, Double-Blind, Placebo -Controlled, Parallel Group Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy.

Read the detailed description

Trials with a new, first -in-class drug will be done to ascertain safety, tolerability, and to explore efficacy in the treatment of rheumatoid arthritis, including its effects on biomarkers. Approximately 240 adult patients with rheumatoid arthritis despite the use of methotrexate therapy will be recruited for the study. They will be randomly assigned to one of 4 treatment arms; each patient has an equal chance of receiving the placebo, or 100 mg, 200 mg, 300 mg dose of RWJ-445380. Patients will take the medication daily for up to 12 weeks. Patients will receive study medication in a blinded fashion, i.e. the patient, the doctor and the study sponsor will not know what group the patient is in until all patients complete the study. The investigator and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will have visits every week for the first 2 weeks then every 2 weeks until 12 weeks of treatment. After 12 weeks, there will be a followup visit 4 weeks after the last dose of study drug is taken. Medical history, physical examination, blood pressure, heart rate, temperature, and ECGs are checked periodically. Joints will be assessed to explore whether the drug might affect tender and swollen joints. Blood samples will be taken for standard safety laboratory tests as well as special tests of the drug blood level, biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation, and other markers for rheumatoid arthritis. Samples will also be taken to see whether certain types of immune cells are affected by taking the drug. Immunization with tetanus vaccine will be done to see if taking the drug might affect immune responses to this agent Patients will receive RWJ-445380, 100, 200, 300 mg, or placebo. Patients will receive oral capsules daily for up to 12 weeks.

Being tested
RWJ-445380 100 mg, RWJ-445380 200 mg, RWJ-445380 300 mg, Placebo
Keywords
Arthritis, Joints, Auto immune
Medical subject headings
Arthritis, Rheumatoid, Arthritis

What participants receive

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

  • RWJ-445380 100 mgDrug

    RWJ-445380 100 mg once daily for up to 12 weeks

  • RWJ-445380 200 mgDrug

    RWJ-445380 200 mg once daily for up to 12 weeks

  • RWJ-445380 300 mgDrug

    RWJ-445380 300 mg once daily for up to 12 weeks

  • PlaceboDrug

    Placebo once daily for up to 12 weeks

Study groups in NCT00425321
Study groupRoleWhat they receive
RWJ-445380 100 mgExperimentalNot described
Receives: Drug: RWJ-445380 100 mg
RWJ-445380 200 mgExperimentalNot described
Receives: Drug: RWJ-445380 200 mg
RWJ-445380 300 mgExperimentalNot described
Receives: Drug: RWJ-445380 300 mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory and physical exam and ECGs in patients with rheumatoid arthritis

    Measured: up to 12 weeks

Secondary outcomes (1)

  1. Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers

    Measured: 12 weeks, Explore effectiveness of drug through accepted clinical measures and biomarkers

Timeline

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

  1. First posted22 Jan 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionJan 2008
  4. Study completionJan 2008

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425321
Sponsor's protocol ID
CR012511
Other IDs
C-2006-009
Status last verified
May 2014
First submitted
19 Jan 2007
Last updated
21 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RWJ-445380 100 mg, RWJ-445380 200 mg and RWJ-445380 300 mg in people with Rheumatoid Arthritis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 42 sites in 7 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 4 inclusion and 6 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 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Germany, Poland, Czechia, Mexico and 2 more countries. 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?

Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory and physical exam and ECGs in patients with rheumatoid arthritis (time frame: up to 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 NCT00425321.

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 21 May 2014.

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