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Rheumatoid ArthritisPhase 2NCT00316771

A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

A Phase 2 study testing P38 Inhibitor (4) 150mg, P38 Inhibitor (4) 25mg and P38 Inhibitor (4) 300mg in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 114 sites in 14 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 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. 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) 150mg, P38 Inhibitor (4) 25mg and P38 Inhibitor (4) 300mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
374 participants
Where
114 sitesin 14 countries
Study dates
Nov 2005to Mar 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

  • adult patients >=18 years of age;
  • active rheumatoid arthritis;
  • current inadequate clinical response to methotrexate.

Who cannot join

  • receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.

Trial locations and contacts

114 sites in 14 countries.

114 sites in 14 countries

United States48 sites

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Atlanta, Georgia, 30303

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Belmont, North Carolina, 28012

  • Study site

    Bend, Oregon, 97701

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Bryan, Texas, 77802

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Carrollton, Texas, 75007

  • Study site

    Escondido, California, 92025

  • Study site

    Everett, Washington, 98201

  • Study site

    Fair Oaks, California, 95628

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Loma Linda, California, 92357

  • Study site

    Lubbock, Texas, 79424

  • Study site

    Macon, Georgia, 31210

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Monroe, Wisconsin, 53566

  • Study site

    Munster, Indiana, 46321

  • Study site

    Nampa, Idaho, 83687

  • Study site

    New Hartford, New York, 13413

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    North Fargo, North Dakota, 58122

  • Study site

    Ocala, Florida, 34474

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Paradise Valley, Arizona, 85253

  • Study site

    Pittsburgh, Pennsylvania, 15237

  • Study site

    Riverside, California, 92501

  • Study site

    Rochester, New York, 14618

  • Study site

    Sarasota, Florida, 34232

  • Study site

    Seattle, Washington, 98133

  • Study site

    Sioux Falls, South Dakota, 57105

  • Study site

    South Bend, Indiana, 46601

  • Study site

    Tamarac, Florida, 33321

  • Study site

    Toms River, New Jersey, 08755

  • Study site

    Traverse City, Michigan, 49684

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85711

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Upland, California, 91786

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Wilkes-Barre, Pennsylvania, 18711

  • Study site

    Worcester, Massachusetts, 01610

Other trials in United States

Canada8 sites

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Mississauga, Ontario, L5M 2V8

  • Study site

    Ottawa, Ontario, K2G 6E2

  • Study site

    Pointe-Claire, Quebec, H9R 3J1

  • Study site

    St. John's, Newfoundland and Labrador, A1A 5E8

  • Study site

    Toronto, Ontario, M4K 1N2

  • Study site

    Toronto, Ontario, M5T 2S8

  • Study site

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Germany8 sites

  • Study site

    Bad Nauheim, 61231

  • Study site

    Berlin, 12200

  • Study site

    Berlin, 14059

  • Study site

    Erfurt, 99096

  • Study site

    Erlangen, 91054

  • Study site

    Leipzig, 04107

  • Study site

    München, 80336

  • Study site

    Wiesbaden, 65191

Other trials in Germany

Spain8 sites

  • Study site

    A Coruña, 15006

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08035

  • Study site

    Córdoba, 14004

  • Study site

    Lugo, 27004

  • Study site

    Madrid, 28034

  • Study site

    Sabadell, 08208

  • Study site

    San Cristóbal de La Laguna, 38320

Other trials in Spain

United Kingdom8 sites

  • Study site

    Basingstoke, RG24 9NA

  • Study site

    Cannock, WS11 5XY

  • Study site

    Harrogate, HG2 7SX

  • Study site

    Leeds, LS7 4SA

  • Study site

    Metropolitan Borough of Wirral, CH49 5PE

  • Study site

    Newcastle upon Tyne, NE1 4LP

  • Study site

    Southampton, SO16 6YD

  • Study site

    Wigan, WN6 9EW

Other trials in United Kingdom

Poland6 sites

  • Study site

    Elblag, 82-300

  • Study site

    Sopot, 81-759

  • Study site

    Szczecin, 71-252

  • Study site

    Torun, 87-100

  • Study site

    Warsaw, 02-256

  • Study site

    Warsaw, 02-637

Other trials in Poland

Greece5 sites

  • Study site

    Athens, 115 27

  • Study site

    Athens, 11521

  • Study site

    Heraklion, 71003

  • Study site

    Ioannina, 455 00

  • Study site

    Thessaloniki, 56403

Other trials in Greece

South Africa5 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Cape Town, 7500

  • Study site

    Durban, 4001

  • Study site

    Johannesburg, 1619

  • Study site

    Pretoria, 0002

Other trials in South Africa

Mexico4 sites

  • Study site

    Guadalajara, 44620

  • Study site

    Mexico City, 03100

  • Study site

    Monterrey, 64460

  • Study site

    San Luis Potosí City, 78240

Other trials in Mexico

Australia3 sites

  • Study site

    Caboolture, 4510

  • Study site

    Fitzroy, 3065

  • Study site

    Kippa-Ring, 4021

Other trials in Australia

Brazil3 sites

  • Study site

    Curitiba, 80060-240

  • Study site

    Goiânia, 74043-110

  • Study site

    São Paulo, 04266-010

Other trials in Brazil

Estonia3 sites

  • Study site

    Tallinn, 10128

  • Study site

    Tallinn, 11312

  • Study site

    Tallinn, 13419

Other trials in Estonia

New Zealand3 sites

  • Study site

    Auckland, 2025

  • Study site

    Christchurch, 8011

  • Study site

    Lower Hutt, 5010

Other trials in New Zealand

Ireland2 sites

  • Study site

    Dublin, 4

  • Study site

    Dublin, 9

Other trials in Ireland

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Study to Determine the Efficacy and Safety of 5 Dose Regimens of RO4402257 in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy.

This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Being tested
P38 Inhibitor (4) 150mg, P38 Inhibitor (4) 25mg, P38 Inhibitor (4) 300mg, P38 Inhibitor (4) 50mg, P38 Inhibitor (4) 75mg
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) 150mgDrug

    150mg po qd

  • P38 Inhibitor (4) 25mgDrug

    25mg po bid

  • P38 Inhibitor (4) 300mgDrug

    300mg po qd

  • P38 Inhibitor (4) 50mgDrug

    50mg po qd

  • P38 Inhibitor (4) 75mgDrug

    75mg po bid

  • PlaceboDrug

    po bid

Study groups in NCT00316771
Study groupRoleWhat they receive
P38 Inhibitor (4) 150mgExperimentalNot described
Receives: Drug: P38 Inhibitor (4) 150mg
P38 Inhibitor (4) 25mgExperimentalNot described
Receives: Drug: P38 Inhibitor (4) 25mg
P38 Inhibitor (4) 300mgExperimentalNot described
Receives: Drug: P38 Inhibitor (4) 300mg
P38 Inhibitor (4) 50mgExperimentalNot described
Receives: Drug: P38 Inhibitor (4) 50mg
P38 Inhibitor (4) 75mgExperimentalNot described
Receives: Drug: P38 Inhibitor (4) 75mg
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of patients with ACR 20 response

    Measured: Week 12

Secondary outcomes (2)

  1. Percentage of patients with ACR 50/70 response

    Measured: Week 12

  2. Change in ACR core set, DAS 28, HAQ disability index, SF-36, withdrawals, AEs, lab 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.

  1. First posted21 Apr 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionMar 2008
  4. Study completionMar 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
Double blind
Who is masked
Participant, Investigator
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00316771
Sponsor's protocol ID
PA18439
Status last verified
Nov 2016
First submitted
20 Apr 2006
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing P38 Inhibitor (4) 150mg, P38 Inhibitor (4) 25mg and P38 Inhibitor (4) 300mg in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 114 sites in 14 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 1 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 114 sites in United States, Canada, Germany, Spain, United Kingdom and 9 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?

On the ClinicalTrials.gov record for NCT00316771.

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.

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