| Characteristic . | All studies (n = 203) . | Published (n = 168) . | Unpublished (n = 35) . | P-value . |
|---|---|---|---|---|
| Study outcome, n (%) | ||||
| Positive | 118 (58.1) | 109 (64.9) | 9 (25.7) | <0.001 |
| Negative | 73 (36.0) | 59 (35.1) | 14 (40.0) | |
| Unknown | 12 (5.9) | 0 | 12 (34.3) | |
| Study sponsor | ||||
| Industry | 144 (70.9) | 120 (71.4) | 24 (68.6) | 0.84 |
| Non-industry | 59 (29.1) | 48 (28.6) | 11 (31.4) | |
| Registration before study start (n = 200), n (%) | ||||
| No | 72 (36.0) | 58 (34.7) | 14 (42.4) | 0.43 |
| Yes | 128 (64.0) | 109 (65.3) | 19 (57.6) | |
| Registration before study completion (n = 201), n (%) | ||||
| No | 20 (10.0) | 13 (7.8) | 7 (20.6) | 0.05 |
| Yes | 181 (90.0) | 154 (92.2) | 27 (79.4) | |
| Year of study completion, n (%) | ||||
| Before 2005 | 9 (4.5) | 8 (4.8) | 1 (2.9) | 0.42 |
| 2005–2009 | 34 (16.8) | 30 (18.0) | 4 (11.4) | |
| 2010–2014 | 70 (34.7) | 60 (35.9) | 10 (28.6) | |
| 2015–2018 | 89 (44.1) | 69 (41.3) | 20 (57.1) | |
| Phase, n (%) | ||||
| II | 86 (42.4) | 63 (37.5) | 23 (65.7) | <0.05 |
| II–III | 11 (5.4) | 9 (5.4) | 2 (5.7) | |
| III | 106 (52.2) | 96 (57.1) | 10 (28.6) | |
| Disease, n (%) | ||||
| Lupus | 70 (34.5) | 53 (31.5) | 17 (48.6) | <0.001 |
| Spondyloarthritis | 43 (21.2) | 39 (23.2) | 4 (11.4) | |
| Psoriatic arthritis | 40 (19.7) | 39 (23.2) | 1 (2.9) | |
| Vasculitis | 31 (15.3) | 27 (16.1) | 4 (11.4) | |
| Sjögren's | 19 (9.4) | 10 (6.0) | 9 (25.7) | |
| Experimental interventional agent, n (%) | ||||
| b/tsDMARD | 140 (69.0) | 120 (71.4) | 20 (57.1) | 0.11 |
| csDMARD | 15 (7.4) | 12 (7.1) | 3 (8.6) | |
| Corticosteroid | 4 (2.0) | 4 (2.4) | 0 | |
| NSAID | 3 (1.5) | 2 (1.2) | 1 (2.9) | |
| PDE inhibitor | 11 (5.4) | 10 (6.0) | 1 (2.9) | |
| Non-pharmacological | 3 (1.5) | 3 (1.8) | 0 | |
| Other | 27 (13.3) | 17 (10.1) | 10 (28.6) | |
| Comparative effectiveness, n (%) | ||||
| Yes | 22 (10.8) | 16 (9.5) | 6 (17.1) | 0.23 |
| No | 181 (89.2) | 152 (90.5) | 29 (82.9) | |
| Masking (n = 202), n (%) | ||||
| Open label/blinded assessor | 28 (13.9) | 21 (12.5) | 7 (20.6) | 0.5 |
| Single blind | 2 (1.0) | 2 (1.2) | 0 | |
| Double blind | 172 (85.1) | 145 (86.3) | 27 (79.4) | |
| Results posted on ClinicalTrials.gov, n (%) | ||||
| Posted | 124 (61.1) | 112 (66.7) | 12 (34.3) | <0.05 |
| No results posted | 72 (35.5) | 51 (30.4) | 21 (60.0) | |
| Submitted without posting | 7 (3.4) | 5 (3.0) | 2 (5.7) | |
| Enrolment (n = 202), median (IQR), n | 183 (69–343) | 199 (99–378) | 57 (34–185) | <0.001 |
| Time to complete trial (n = 202), median (IQR), days | 762 (548–1162) | 762 (554–1183) | 760 (524–1068) | 0.5 |
| Characteristic . | All studies (n = 203) . | Published (n = 168) . | Unpublished (n = 35) . | P-value . |
|---|---|---|---|---|
| Study outcome, n (%) | ||||
| Positive | 118 (58.1) | 109 (64.9) | 9 (25.7) | <0.001 |
| Negative | 73 (36.0) | 59 (35.1) | 14 (40.0) | |
| Unknown | 12 (5.9) | 0 | 12 (34.3) | |
| Study sponsor | ||||
| Industry | 144 (70.9) | 120 (71.4) | 24 (68.6) | 0.84 |
| Non-industry | 59 (29.1) | 48 (28.6) | 11 (31.4) | |
| Registration before study start (n = 200), n (%) | ||||
| No | 72 (36.0) | 58 (34.7) | 14 (42.4) | 0.43 |
| Yes | 128 (64.0) | 109 (65.3) | 19 (57.6) | |
| Registration before study completion (n = 201), n (%) | ||||
| No | 20 (10.0) | 13 (7.8) | 7 (20.6) | 0.05 |
| Yes | 181 (90.0) | 154 (92.2) | 27 (79.4) | |
| Year of study completion, n (%) | ||||
| Before 2005 | 9 (4.5) | 8 (4.8) | 1 (2.9) | 0.42 |
| 2005–2009 | 34 (16.8) | 30 (18.0) | 4 (11.4) | |
| 2010–2014 | 70 (34.7) | 60 (35.9) | 10 (28.6) | |
| 2015–2018 | 89 (44.1) | 69 (41.3) | 20 (57.1) | |
| Phase, n (%) | ||||
| II | 86 (42.4) | 63 (37.5) | 23 (65.7) | <0.05 |
| II–III | 11 (5.4) | 9 (5.4) | 2 (5.7) | |
| III | 106 (52.2) | 96 (57.1) | 10 (28.6) | |
| Disease, n (%) | ||||
| Lupus | 70 (34.5) | 53 (31.5) | 17 (48.6) | <0.001 |
| Spondyloarthritis | 43 (21.2) | 39 (23.2) | 4 (11.4) | |
| Psoriatic arthritis | 40 (19.7) | 39 (23.2) | 1 (2.9) | |
| Vasculitis | 31 (15.3) | 27 (16.1) | 4 (11.4) | |
| Sjögren's | 19 (9.4) | 10 (6.0) | 9 (25.7) | |
| Experimental interventional agent, n (%) | ||||
| b/tsDMARD | 140 (69.0) | 120 (71.4) | 20 (57.1) | 0.11 |
| csDMARD | 15 (7.4) | 12 (7.1) | 3 (8.6) | |
| Corticosteroid | 4 (2.0) | 4 (2.4) | 0 | |
| NSAID | 3 (1.5) | 2 (1.2) | 1 (2.9) | |
| PDE inhibitor | 11 (5.4) | 10 (6.0) | 1 (2.9) | |
| Non-pharmacological | 3 (1.5) | 3 (1.8) | 0 | |
| Other | 27 (13.3) | 17 (10.1) | 10 (28.6) | |
| Comparative effectiveness, n (%) | ||||
| Yes | 22 (10.8) | 16 (9.5) | 6 (17.1) | 0.23 |
| No | 181 (89.2) | 152 (90.5) | 29 (82.9) | |
| Masking (n = 202), n (%) | ||||
| Open label/blinded assessor | 28 (13.9) | 21 (12.5) | 7 (20.6) | 0.5 |
| Single blind | 2 (1.0) | 2 (1.2) | 0 | |
| Double blind | 172 (85.1) | 145 (86.3) | 27 (79.4) | |
| Results posted on ClinicalTrials.gov, n (%) | ||||
| Posted | 124 (61.1) | 112 (66.7) | 12 (34.3) | <0.05 |
| No results posted | 72 (35.5) | 51 (30.4) | 21 (60.0) | |
| Submitted without posting | 7 (3.4) | 5 (3.0) | 2 (5.7) | |
| Enrolment (n = 202), median (IQR), n | 183 (69–343) | 199 (99–378) | 57 (34–185) | <0.001 |
| Time to complete trial (n = 202), median (IQR), days | 762 (548–1162) | 762 (554–1183) | 760 (524–1068) | 0.5 |
b/tsDMARD: biologic or targeted synthetic DMARD; csDMARD: conventional synthetic DMARD; IQR: interquartile range; PDE: phosphodiesterase; RCT: randomized controlled trial.
| Characteristic . | All studies (n = 203) . | Published (n = 168) . | Unpublished (n = 35) . | P-value . |
|---|---|---|---|---|
| Study outcome, n (%) | ||||
| Positive | 118 (58.1) | 109 (64.9) | 9 (25.7) | <0.001 |
| Negative | 73 (36.0) | 59 (35.1) | 14 (40.0) | |
| Unknown | 12 (5.9) | 0 | 12 (34.3) | |
| Study sponsor | ||||
| Industry | 144 (70.9) | 120 (71.4) | 24 (68.6) | 0.84 |
| Non-industry | 59 (29.1) | 48 (28.6) | 11 (31.4) | |
| Registration before study start (n = 200), n (%) | ||||
| No | 72 (36.0) | 58 (34.7) | 14 (42.4) | 0.43 |
| Yes | 128 (64.0) | 109 (65.3) | 19 (57.6) | |
| Registration before study completion (n = 201), n (%) | ||||
| No | 20 (10.0) | 13 (7.8) | 7 (20.6) | 0.05 |
| Yes | 181 (90.0) | 154 (92.2) | 27 (79.4) | |
| Year of study completion, n (%) | ||||
| Before 2005 | 9 (4.5) | 8 (4.8) | 1 (2.9) | 0.42 |
| 2005–2009 | 34 (16.8) | 30 (18.0) | 4 (11.4) | |
| 2010–2014 | 70 (34.7) | 60 (35.9) | 10 (28.6) | |
| 2015–2018 | 89 (44.1) | 69 (41.3) | 20 (57.1) | |
| Phase, n (%) | ||||
| II | 86 (42.4) | 63 (37.5) | 23 (65.7) | <0.05 |
| II–III | 11 (5.4) | 9 (5.4) | 2 (5.7) | |
| III | 106 (52.2) | 96 (57.1) | 10 (28.6) | |
| Disease, n (%) | ||||
| Lupus | 70 (34.5) | 53 (31.5) | 17 (48.6) | <0.001 |
| Spondyloarthritis | 43 (21.2) | 39 (23.2) | 4 (11.4) | |
| Psoriatic arthritis | 40 (19.7) | 39 (23.2) | 1 (2.9) | |
| Vasculitis | 31 (15.3) | 27 (16.1) | 4 (11.4) | |
| Sjögren's | 19 (9.4) | 10 (6.0) | 9 (25.7) | |
| Experimental interventional agent, n (%) | ||||
| b/tsDMARD | 140 (69.0) | 120 (71.4) | 20 (57.1) | 0.11 |
| csDMARD | 15 (7.4) | 12 (7.1) | 3 (8.6) | |
| Corticosteroid | 4 (2.0) | 4 (2.4) | 0 | |
| NSAID | 3 (1.5) | 2 (1.2) | 1 (2.9) | |
| PDE inhibitor | 11 (5.4) | 10 (6.0) | 1 (2.9) | |
| Non-pharmacological | 3 (1.5) | 3 (1.8) | 0 | |
| Other | 27 (13.3) | 17 (10.1) | 10 (28.6) | |
| Comparative effectiveness, n (%) | ||||
| Yes | 22 (10.8) | 16 (9.5) | 6 (17.1) | 0.23 |
| No | 181 (89.2) | 152 (90.5) | 29 (82.9) | |
| Masking (n = 202), n (%) | ||||
| Open label/blinded assessor | 28 (13.9) | 21 (12.5) | 7 (20.6) | 0.5 |
| Single blind | 2 (1.0) | 2 (1.2) | 0 | |
| Double blind | 172 (85.1) | 145 (86.3) | 27 (79.4) | |
| Results posted on ClinicalTrials.gov, n (%) | ||||
| Posted | 124 (61.1) | 112 (66.7) | 12 (34.3) | <0.05 |
| No results posted | 72 (35.5) | 51 (30.4) | 21 (60.0) | |
| Submitted without posting | 7 (3.4) | 5 (3.0) | 2 (5.7) | |
| Enrolment (n = 202), median (IQR), n | 183 (69–343) | 199 (99–378) | 57 (34–185) | <0.001 |
| Time to complete trial (n = 202), median (IQR), days | 762 (548–1162) | 762 (554–1183) | 760 (524–1068) | 0.5 |
| Characteristic . | All studies (n = 203) . | Published (n = 168) . | Unpublished (n = 35) . | P-value . |
|---|---|---|---|---|
| Study outcome, n (%) | ||||
| Positive | 118 (58.1) | 109 (64.9) | 9 (25.7) | <0.001 |
| Negative | 73 (36.0) | 59 (35.1) | 14 (40.0) | |
| Unknown | 12 (5.9) | 0 | 12 (34.3) | |
| Study sponsor | ||||
| Industry | 144 (70.9) | 120 (71.4) | 24 (68.6) | 0.84 |
| Non-industry | 59 (29.1) | 48 (28.6) | 11 (31.4) | |
| Registration before study start (n = 200), n (%) | ||||
| No | 72 (36.0) | 58 (34.7) | 14 (42.4) | 0.43 |
| Yes | 128 (64.0) | 109 (65.3) | 19 (57.6) | |
| Registration before study completion (n = 201), n (%) | ||||
| No | 20 (10.0) | 13 (7.8) | 7 (20.6) | 0.05 |
| Yes | 181 (90.0) | 154 (92.2) | 27 (79.4) | |
| Year of study completion, n (%) | ||||
| Before 2005 | 9 (4.5) | 8 (4.8) | 1 (2.9) | 0.42 |
| 2005–2009 | 34 (16.8) | 30 (18.0) | 4 (11.4) | |
| 2010–2014 | 70 (34.7) | 60 (35.9) | 10 (28.6) | |
| 2015–2018 | 89 (44.1) | 69 (41.3) | 20 (57.1) | |
| Phase, n (%) | ||||
| II | 86 (42.4) | 63 (37.5) | 23 (65.7) | <0.05 |
| II–III | 11 (5.4) | 9 (5.4) | 2 (5.7) | |
| III | 106 (52.2) | 96 (57.1) | 10 (28.6) | |
| Disease, n (%) | ||||
| Lupus | 70 (34.5) | 53 (31.5) | 17 (48.6) | <0.001 |
| Spondyloarthritis | 43 (21.2) | 39 (23.2) | 4 (11.4) | |
| Psoriatic arthritis | 40 (19.7) | 39 (23.2) | 1 (2.9) | |
| Vasculitis | 31 (15.3) | 27 (16.1) | 4 (11.4) | |
| Sjögren's | 19 (9.4) | 10 (6.0) | 9 (25.7) | |
| Experimental interventional agent, n (%) | ||||
| b/tsDMARD | 140 (69.0) | 120 (71.4) | 20 (57.1) | 0.11 |
| csDMARD | 15 (7.4) | 12 (7.1) | 3 (8.6) | |
| Corticosteroid | 4 (2.0) | 4 (2.4) | 0 | |
| NSAID | 3 (1.5) | 2 (1.2) | 1 (2.9) | |
| PDE inhibitor | 11 (5.4) | 10 (6.0) | 1 (2.9) | |
| Non-pharmacological | 3 (1.5) | 3 (1.8) | 0 | |
| Other | 27 (13.3) | 17 (10.1) | 10 (28.6) | |
| Comparative effectiveness, n (%) | ||||
| Yes | 22 (10.8) | 16 (9.5) | 6 (17.1) | 0.23 |
| No | 181 (89.2) | 152 (90.5) | 29 (82.9) | |
| Masking (n = 202), n (%) | ||||
| Open label/blinded assessor | 28 (13.9) | 21 (12.5) | 7 (20.6) | 0.5 |
| Single blind | 2 (1.0) | 2 (1.2) | 0 | |
| Double blind | 172 (85.1) | 145 (86.3) | 27 (79.4) | |
| Results posted on ClinicalTrials.gov, n (%) | ||||
| Posted | 124 (61.1) | 112 (66.7) | 12 (34.3) | <0.05 |
| No results posted | 72 (35.5) | 51 (30.4) | 21 (60.0) | |
| Submitted without posting | 7 (3.4) | 5 (3.0) | 2 (5.7) | |
| Enrolment (n = 202), median (IQR), n | 183 (69–343) | 199 (99–378) | 57 (34–185) | <0.001 |
| Time to complete trial (n = 202), median (IQR), days | 762 (548–1162) | 762 (554–1183) | 760 (524–1068) | 0.5 |
b/tsDMARD: biologic or targeted synthetic DMARD; csDMARD: conventional synthetic DMARD; IQR: interquartile range; PDE: phosphodiesterase; RCT: randomized controlled trial.
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