A Phase 3 interventional study of fostamatinib and fostamatinib in Rheumatoid Arthritis, sponsored by AstraZeneca. Completed at 127 sites in 17 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-07.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
Sub-study:
Full title: Optional Genetic Research
Date: 18 June 2010
Version: 1
Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 923 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral Treatment
Drug: fostamatinib
Oral Treatment
Drug: fostamatinib
Oral Treatment
Drug: placebo, fostamatinib
fostamatinib 100 mg twice daily
fostamatinib 100 mg twice daily/150 mg once daily
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
Time frame: 24 weeks
Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.
mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.
Time frame: Baseline and 24 weeks
ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.
Time frame: 1 week
Proportion of Patients Achieving ACR50 up to Week 24
ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
Time frame: 24 weeks
Proportion of Patients Achieving ACR70 up to Week 24
ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
Time frame: 24 weeks
ACRn - Comparison Between Fostamatinib and Placebo at Week 24
ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.
Time frame: 24 weeks
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Time frame: 12 weeks
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Time frame: 24 weeks
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Time frame: 24 weeks
HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Time frame: Baseline and 24 weeks
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
Time frame: Baseline and 24 weeks
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
Time frame: Baseline and 24 weeks
A total of 1475 patients were enrolled: 311, 306 \& 306 were randomised to Groups A, B \& C, respectively (310, 304 \& 304 received at least 1 dose of IP).
| Milestone | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| Started | 310 | 304 | 304 |
| Randomised but did not receive treatment | 1 | 2 | 2 |
| Completed | 207 | 191 | 161 |
| Not completed | 103 | 113 | 143 |
| Withdrew: Not reported | 24 | 25 | 21 |
| Withdrew: Enrolment in long term extension | 42 | 36 | 87 |
| Withdrew: Severe non-compliance to protocol | 1 | 3 | 3 |
| Withdrew: Lack of therapeutic response | 2 | 3 | 4 |
| Withdrew: Dev. of study specific discont. criteria | 6 | 16 | 2 |
| Withdrew: Lost to follow-up | 3 | 2 | 2 |
| Withdrew: Adverse event | 25 | 28 | 24 |
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
| Percentage of responders | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo. | 49.0 | 44.4 | 34.2 |
mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.
| Units on a scale | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo. | 0.45 ± 2.201 | 1.29 ± 13.380 | 0.13 ± 2.142 |
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.
| Percentage of responders | FOSTA 100 MG BID (Combined) | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|
| ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1 | 18.2 | 4.9 |
ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
| Percentage of responders | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| Proportion of Patients Achieving ACR50 up to Week 24 | 26.1 | 18.4 | 9.9 |
ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
| Percentage of responders | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| Proportion of Patients Achieving ACR70 up to Week 24 | 10.3 | 5.6 | 2.0 |
ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.
| Percentage improvement from baseline | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| ACRn - Comparison Between Fostamatinib and Placebo at Week 24 | 26.13 ± 30.833 | 20.06 ± 28.599 | 12.92 ± 26.611 |
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
| Percentage of responders | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12 | 10.3 | 7.9 | 2.0 |
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
| Percentage of responders | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24 | 13.2 | 8.6 | 4.9 |
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
| Percentage of responders | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| No response | 34.8 ± 1.46 | 41.1 ± 1.34 | 53.0 ± 1.30 |
| Moderate response | 39.0 | 44.4 | 36.2 |
| Good response | 26.1 | 14.5 | 10.9 |
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
| Percentage of responders | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24 | 54.8 | 50.3 | 35.2 |
SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
| Units on a scale | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24 | 6 ± 8.0 | 5 ± 6.7 | 3 ± 6.2 |
SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
| Units on a scale | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO |
|---|---|---|---|
| SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24 | 4 ± 9.5 | 4 ± 8.6 | 2 ± 8.1 |
Collected over 52 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FOSTA 100 MG BID | — | 24/310 (7.7%) | 169/310 (54.5%) |
| FOSTA 100 MG BID (4 WKS) THEN 150 MG QD | — | 24/304 (7.9%) | 191/304 (62.8%) |
| PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period | — | 12/304 (3.9%) | 64/304 (21.1%) |
| PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period | — | 5/304 (1.6%) | 80/304 (26.3%) |
| Event | FOSTA 100 MG BID | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD | PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period | PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period |
|---|---|---|---|---|
| GASTROENTERITISInfections and infestations | 1/310 | 3/304 | 0/304 | 0/304 |
| ATRIAL FIBRILLATIONCardiac disorders | 0/310 | 2/304 | 1/304 | 0/304 |
| CHOLELITHIASISHepatobiliary disorders | 2/310 | 0/304 | 0/304 | 0/304 |
| CELLULITISInfections and infestations | 2/310 | 0/304 | 0/304 | 0/304 |
| RHEUMATOID ARTHRITISMusculoskeletal and connective tissue disorders | 2/310 | 0/304 | 1/304 | 0/304 |
| ANAEMIABlood and lymphatic system disorders | 0/310 | 1/304 | 0/304 | 0/304 |
| ACUTE MYOCARDIAL INFARCTIONCardiac disorders | 0/310 | 1/304 | 0/304 | 0/304 |
| ATRIAL FLUTTERCardiac disorders | 0/310 | 1/304 | 0/304 | 0/304 |
| CARDIAC FAILURECardiac disorders | 0/310 | 0/304 | 0/304 | 1/304 |
| CARDIAC FAILURE ACUTECardiac disorders | 0/310 | 1/304 | 0/304 | 0/304 |
| Event | FOSTA 100 MG BID | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD | PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period | PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period |
|---|---|---|---|---|
| DIARRHOEAGastrointestinal disorders | 60/310 | 63/304 | 18/304 | 12/304 |
| HYPERTENSIONVascular disorders | 59/310 | 58/304 | 11/304 | 12/304 |
| NASOPHARYNGITISInfections and infestations | 22/310 | 28/304 | 6/304 | 11/304 |
| NAUSEAGastrointestinal disorders | 19/310 | 27/304 | 8/304 | 11/304 |
| ALANINE AMINOTRANSFERASE INCREASEDInvestigations | 22/310 | 22/304 | 8/304 | 5/304 |
| HEADACHENervous system disorders | 15/310 | 20/304 | 7/304 | 12/304 |
| VOMITINGGastrointestinal disorders | 18/310 | 8/304 | 5/304 | 5/304 |
| URINARY TRACT INFECTION BACTERIALInfections and infestations | 18/310 | 14/304 | 6/304 | 6/304 |
| BACK PAINMusculoskeletal and connective tissue disorders | 18/310 | 8/304 | 2/304 | 2/304 |
| BLOOD PRESSURE INCREASEDInvestigations | 17/310 | 16/304 | 4/304 | 5/304 |
| Age, Continuous(years) | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO | Total |
|---|---|---|---|---|
| Mean | 52 ± 12.2 | 52 ± 12.0 | 53 ± 11.9 | 52 ± 12.0 |
| Sex: Female, Male(Participants) | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO | Total |
|---|---|---|---|---|
| Female | 263 | 254 | 253 | 770 |
| Male | 47 | 50 | 51 | 148 |
| Race/Ethnicity, Customized(Participants) | FOSTA 100 MG BID PO | FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO | PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO | Total |
|---|---|---|---|---|
| White | 218 | 213 | 209 | 640 |
| Black or African American | 9 | 5 | 11 | 25 |
| Asian | 3 | 10 | 5 | 18 |
| American Indian or Alaska Native | 14 | 12 | 11 | 37 |
| Indian or Pakistani | 20 | 14 | 19 | 53 |
| Other | 46 | 50 | 49 | 145 |
Showing the first 100 of 127 sites across 17 countries.
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca