Rheumatoid ArthritisPhase 2NCT00369928
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
A Phase 2 study testing PG-760564 in people with Rheumatoid Arthritis, run by Procter and Gamble at 53 sites in 6 countries.
Trial summary
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- PG-760564
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 53 sitesin 6 countries
- Study dates
- Aug 2006to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
- Disease duration of at least 6 months
- Must be treated with Methotrexate for at least 24 weeks
- At least 6 swollen joints and 6 tender joints
- Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
- Women of childbearing age and all males must use acceptable method of birth control
Who cannot join
- Tuberculosis
- Malignancies
- Abnormal electrocardiograms as described in the protocol
- Current infection or recurrent infections or immunodeficiency
- Liver diseases and abnormalities in liver function tests as described in the protocol
- Autoimmune diseases other than RA except Sjogren's syndrome secondary to RA;
- History of demyelization diseases
- Any condition that in the opinion of the investigator could be detrimental to patients enrolling in the study including clinically important changes in laboratory values and other diseases described in the protocol
Trial locations and contacts
53 sites in 6 countries.
53 sites in 6 countries
United States24 sites
Research Facility
Austin, Texas, 78705
Research Facility
Beverly Hills, California, 90211
Research Facility
Charlotte, North Carolina, 28209
Research Facility
Chiefland, Florida, 32626
Research Facility
Dallas, Texas, 75231
Research Facility
Dallas, Texas, 75235
Research Facility
Decatur, Georgia, 30033
Research Facility
Duncansville, Pennsylvania, 16635
Research Facility
Dunedin, Florida, 34698
Research Facility
Elizabeth, New Jersey, 07202
Research Facility
Erie, Pennsylvania, 16508
Research Facility
Fort Lauderdale, Florida, 33334
Research Facility
Hot Springs, Arkansas, 71913
Research Facility
Marietta, Georgia, 30060
Research Facility
Meridian, Idaho, 83642
Research Facility
Minot, North Dakota, 58701
Research Facility
Mission Viejo, California, 92691
Research Facility
New Orleans, Louisiana, 70121
Research Facility
Omaha, Nebraska, 68134
Research Facility
Plainview, New York, 11803
Research Facility
Rome, Georgia, 30165
Research Facility
San Antonio, Texas, 78217
Research Facility
Tavares, Florida, 32778
Research Facility
Wilmington, North Carolina, 28401
Poland13 sites
Research Facility
Częstochowa, Częstochowa, 42-200
Research Facility
Działdowo, Działdowo, 13-200
Research Facility
Elblag, Elbląg, 83-300
Research Facility
Gmina Końskie, Konskie, 26-200
Research Facility
Krakow, Krakow, 30-510
Research Facility
Krakow, Krakow, 31-121
Research Facility
Lodz, Łódź Voivodeship, 33-513
Research Facility
Lublin, Lublin Voivodeship, 20-954
Research Facility
Poznan, Poznań, 60-733
Research Facility
Sopot, Sopot, 81-759
Research Facility
Szczecin, Szczecin, 71-252
Research Facility
Torun, Torun, 85-168
Research Facility
Warsaw, Warszawa, 00-909
Hungary6 sites
Research Facility
Balatonfüred
Research Facility
Budapest
Research Facility
Eger
Research Facility
Győr
Research Facility
Gyula
Research Facility
Szolnok
Czechia5 sites
Research Facility
Česká Lípa
Research Facility
Hustopeče
Research Facility
Prague
Research Facility
Uherské Hradiště
Research Facility
Zlín
United Kingdom4 sites
Research Facility
Ashford, Ashford, TW15 3AA
Research Facility
Cambridge, Cambridge
Research Facility
Glasgow, Glasgow, G20 0XA
Research Facility
Liverpool, Liverpool, L9 7AL
About this study
Official title: A Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
Read the detailed description
The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.
The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.
After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.
The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- PG-760564, Placebo dose
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG-760564Drug
100 mg BID, of oral PG-760564
Placebo doseDrug
placebo, BID, oral for 12 weeks
PG-760564Drug
25 mg BID, of oral PG-760564
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, oral dose, BID Receives: Drug: Placebo dose |
| 25 mg PG-760564 | Experimental | 25 mg BID, of oral PG-760564 Receives: Drug: PG-760564 |
| 100 mg PG-760564 | Experimental | 100 mg BID, of oral PG-760564 Receives: Drug: PG-760564 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Muhammad Rehman, MD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369928
- Sponsor's protocol ID
- 2006012
- Status last verified
- Aug 2011
- First submitted
- 29 Aug 2006
- Last updated
- 8 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG-760564 in Adult Patients With RA Receiving Methotrexate
- ClinicalTrials.gov ID
- NCT00369928
- Acronym / sponsor ID
- 2006012
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Aug 2006 (estimated)
- Results
- Posted 8 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
Detailed description
The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study.
The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept.
After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit.
The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo dosePlacebo, oral dose, BID |
| 25 mg PG-760564 | Experimental | Drug: PG-76056425 mg BID, of oral PG-760564 |
| 100 mg PG-760564 | Experimental | Drug: PG-760564100 mg BID, of oral PG-760564 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet American College of Rheumatology (ACR) criteria for Rheumatoid Arthritis
- Disease duration of at least 6 months
- Must be treated with Methotrexate for at least 24 weeks
- At least 6 swollen joints and 6 tender joints
- Washout required for other Disease Modifying Anti-rheumatic Drugs (DMARDs)
Key exclusion criteria (8 listed)
- Tuberculosis
- Malignancies
- Abnormal electrocardiograms as described in the protocol
- Current infection or recurrent infections or immunodeficiency
- Liver diseases and abnormalities in liver function tests as described in the protocol
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 |
|---|---|---|
| PG-760564100 mg BID, of oral PG-760564 | Drug | 100 mg PG-760564 |
| Placebo doseplacebo, BID, oral for 12 weeks | Drug | Placebo |
| PG-76056425 mg BID, of oral PG-760564 | Drug | 25 mg PG-760564 |
Primary outcome
Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
Time frame: 12 weeks
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Muhammad Rehman, MD study director
Procter and Gamble
53 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG-760564 in people with Rheumatoid Arthritis, run by Procter and Gamble at 53 sites in 6 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 6 inclusion and 8 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 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Poland, Hungary, Czechia, United Kingdom and 1 more country. 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?
Yes. Results are posted in the registry (first posted 8 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks (time frame: 12 weeks). 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 8 Sep 2011.