A Phase 2 interventional study of PG-760564 and Placebo dose in Rheumatoid Arthritis, sponsored by Procter and Gamble. Completed at 53 sites in 6 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2011-09-08.
Sponsored by Procter and Gamble · Phase 2, Interventional, and Treatment
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.
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.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 254 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Procter and Gamble is the lead sponsor of 83 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Placebo, oral dose, BID
Drug: Placebo dose
25 mg BID, of oral PG-760564
Drug: PG-760564
100 mg BID, of oral PG-760564
Drug: PG-760564
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
Time frame: 12 weeks
| Milestone | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID |
|---|---|---|---|
| Started | 85 | 85 | 86 |
| Completed | 77 | 69 | 66 |
| Not completed | 8 | 16 | 20 |
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
| percent meeting ACR 20 | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID |
|---|---|---|---|
| Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks | 60 (48 to 72) | 56 (43 to 68) | 54 (41 to 67) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 1/85 (1.2%) | 3/85 (3.5%) |
| 25 mg PG-760564 BID | — | 4/85 (4.7%) | 2/85 (2.4%) |
| 100 mg PG-760564 BID | — | 6/86 (7%) | 5/86 (5.8%) |
| Event | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID |
|---|---|---|---|
| PneumoniaInfections and infestations | 0/85 | 1/85 | 1/86 |
| UrosepsisInfections and infestations | 1/85 | 0/85 | 0/86 |
| Viral InfectionInfections and infestations | 0/85 | 1/85 | 0/86 |
| Intervertebral disc degenerationMusculoskeletal and connective tissue disorders | 0/85 | 1/85 | 0/86 |
| Pulmonary granulomaRespiratory, thoracic and mediastinal disorders | 0/85 | 1/85 | 0/86 |
| Deep vein thrombosisVascular disorders | 1/85 | 0/85 | 0/86 |
| HaemorrhoidsGastrointestinal disorders | 0/85 | 0/85 | 1/86 |
| PyrexiaGeneral disorders | 0/85 | 0/85 | 1/86 |
| Rheumatoid ArthritisMusculoskeletal and connective tissue disorders | 0/85 | 0/85 | 1/86 |
| Suicide AttemptPsychiatric disorders | 0/85 | 0/85 | 1/86 |
| Event | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID |
|---|---|---|---|
| Alanine aminotransferase increasedInvestigations | 3/85 | 2/85 | 5/86 |
| Age, Categorical(Participants) | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 75 | 78 | 79 | 232 |
| >=65 years | 10 | 7 | 7 | 24 |
| Age Continuous(years) | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID | Total |
|---|---|---|---|---|
| Mean | 51.52 ± 11.04 | 50.39 ± 11.68 | 54.70 ± 9.31 | 52.21 ± 10.83 |
| Sex: Female, Male(Participants) | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID | Total |
|---|---|---|---|---|
| Female | 64 | 65 | 66 | 195 |
| Male | 21 | 20 | 20 | 61 |
| Region of Enrollment(participants) | Placebo | 25 mg PG-760564 BID | 100 mg PG-760564 BID | Total |
|---|---|---|---|---|
| United States | 9 | 11 | 9 | 29 |
| Poland | 45 | 42 | 49 | 136 |
| United Kingdom | 3 | 0 | 0 | 3 |
| Czech Republic | 18 | 23 | 16 | 57 |
| Hungary | 10 | 9 | 12 | 31 |
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PG-760564