Rheumatoid ArthritisPhase 2NCT00303563
A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis
A Phase 2 study testing P38 Inhibitor (4) in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 61 sites in 12 countries.
Trial summary
This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. 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?
- P38 Inhibitor (4)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 61 sitesin 12 countries
- Study dates
- Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients >18 years of age, with active RA;
- receiving treatment for RA on an outpatient basis;
- females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.
Who cannot join
- major surgery within 8 weeks prior to screening;
- rheumatic autoimmune disease or inflammatory joint disease other than RA;
- treatment with methotrexate within 8 weeks of baseline;
- concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.
Trial locations and contacts
61 sites in 12 countries.
61 sites in 12 countries
United States22 sites
Study site
Amarillo, Texas, 79106
Study site
Anniston, Alabama, 36207
Study site
Belmont, North Carolina, 28012
Study site
Bend, Oregon, 97701
Study site
Charleston, South Carolina, 29407
Study site
Dallas, Texas, 75231
Study site
Danville, Pennsylvania, 17822
Study site
Escondido, California, 92025
Study site
Knoxville, Tennessee, 37909
Study site
Lancaster, Pennsylvania, 17604
Study site
Loma Linda, California, 92357
Study site
Louisville, Kentucky, 40292
Study site
Memphis, Tennessee, 38104
Study site
Morton Grove, Illinois, 60053
Study site
Nashville, Tennessee, 37203
Study site
New Orleans, Louisiana, 70115
Study site
Scottsdale, Arizona, 85251
Study site
South Bend, Indiana, 46601
Study site
Stamford, Connecticut, 06905
Study site
Tucson, Arizona, 85704
Study site
Tucson, Arizona, 85712
Study site
Wichita, Kansas, 67207
Spain8 sites
Study site
A Coruña, 15006
Study site
Barcelona, 08035
Study site
Granada, 18014
Study site
Jerez de la Frontera, 11407
Study site
Madrid, 28040
Study site
Oviedo, 33006
Study site
Palma de Mallorca, 07007
Study site
Seville, 41013
France5 sites
Study site
Brest, 29609
Study site
Corbeil-Essonnes, 91106
Study site
Montpellier, 34295
Study site
Paris, 75679
Study site
Rouen, 76031
Canada4 sites
Study site
Edmonton, Alberta, T5H 3V9
Study site
Halifax, Nova Scotia, B3H 2Y9
Study site
Ottawa, Ontario, K2G 6E2
Study site
Toronto, Ontario, M5T 2S8
Czechia4 sites
Study site
České Budějovice, 370 01
Study site
Prague, 128 50
Study site
Terezín, 411 55
Study site
Zlín, 760 01
Italy4 sites
Study site
Brescia, 25123
Study site
Genova, 16132
Study site
Pavia, 27100
Study site
Roma, 00161
Mexico3 sites
Study site
Guadalajara, 44340
Study site
Guadalajara, 44620
Study site
Miexico City, 06700
South Africa3 sites
Study site
Bloemfontein, 9301
Study site
Johannesburg, 1619
Study site
Pretoria, 0002
Taiwan3 sites
Study site
Kaohsiung City, 00833
Study site
Taoyuan, 333
Study site
Tapei, 114
About this study
Official title: A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.
This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
- Conditions
- Rheumatoid Arthritis
- Being tested
- P38 Inhibitor (4), Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P38 Inhibitor (4)Drug
50mg po qd
P38 Inhibitor (4)Drug
150mg po qd
P38 Inhibitor (4)Drug
300mg po qd
PlaceboDrug
po qd
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: P38 Inhibitor (4) |
| 2 | Experimental | Not described Receives: Drug: P38 Inhibitor (4) |
| 3 | Experimental | Not described Receives: Drug: P38 Inhibitor (4) |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with ACR 20 response
Measured: Week 12
Secondary outcomes (2)
Percentage of patients with ACR 50/70 response.
Measured: Week 12
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303563
- Sponsor's protocol ID
- PA18604
- Status last verified
- Nov 2016
- First submitted
- 16 Mar 2006
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study to Compare the Effect of RO4402257 Monotherapy and Methotrexate Monotherapy on Disease Response in Patients With Active Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00303563
- Acronym / sponsor ID
- PA18604
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 17 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: P38 Inhibitor (4) |
| 2 | Experimental | Drug: P38 Inhibitor (4) |
| 3 | Experimental | Drug: P38 Inhibitor (4) |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients >18 years of age, with active RA;
- receiving treatment for RA on an outpatient basis;
- females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.
Key exclusion criteria (4 listed)
- major surgery within 8 weeks prior to screening;
- rheumatic autoimmune disease or inflammatory joint disease other than RA;
- treatment with methotrexate within 8 weeks of baseline;
- concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P38 Inhibitor (4)50mg po qd | Drug | 1 |
| P38 Inhibitor (4)150mg po qd | Drug | 2 |
| P38 Inhibitor (4)300mg po qd | Drug | 3 |
| Placebopo qd | Drug | 4 |
Primary outcome
Percentage of patients with ACR 20 response
Time frame: Week 12
2 secondary outcomes
Percentage of patients with ACR 50/70 response.
Time frame: Week 12
Change in ACR core set, DAS 28, FACIT-F fatigue assessment, AEs, laboratory parameters.
Time frame: Throughout study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
61 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing P38 Inhibitor (4) in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 61 sites in 12 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 3 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Spain, France, Canada, Czechia and 7 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?
Percentage of patients with ACR 20 response (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.