Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis

Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01850966
Collaborator
(none)
2,747
453
19
6.1
0.3

Study Details

Study Description

Brief Summary

To investigate the safety and efficacy of the administration of Iguratimod (CRM01T) for 52 weeks in patients with rheumatoid arthritis in clinical practice

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
2747 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Investigation of the Safety and Efficacy of Iguratimod in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Sep 12, 2012
Actual Primary Completion Date :
Apr 13, 2014
Actual Study Completion Date :
Apr 13, 2014

Arms and Interventions

Arm Intervention/Treatment
Iguratimod

Drug: Iguratimod
The usual adult dosage for oral use of 25 mg tablet of iguratimod once daily for 4 weeks or more, after which the dosage should be increased to one 25 mg tablet taken twice daily.

Outcome Measures

Primary Outcome Measures

  1. Disease Activity Score (DAS28) for Rheumatoid Arthritis (EULAR Response Criteria) [52 weeks (0-24 weeks and 25-52 weeks)]

    DAS28 is a quantitative tool used to measure and monitor disease activity and treatment of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. Good response: Baseline DAS28 less than or equal to 3.2 (low disease activity); DAS28 Improvement >1.2 Moderate response: Baseline DAS28 less than or equal to 3.2; DAS28 Improvement >0.6 and less than or equal to 1.2 or Baseline DAS28 >3.2 and less than or equal to 5.1; DAS28 Improvement >0.6 or Baseline DAS28 >5.1; DAS28 Improvement >1.2 No response: Baseline DAS28 >5.1 (high disease activity); DAS28 Improvement less than or equal to 1.2 or DAS28 Improvement less than or equal to 0.6

Secondary Outcome Measures

  1. Number of Participants with Adverse Events [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Inclusion criteria

  • Participants with rheumatoid arthritis

  • Participants who take iguratimod

Exclusion criteria

  • Participants registered for this survey previously

  • Pregnant women or women suspected of being pregnant

  • Participants with a serious liver disorder

  • Participants with peptic ulcer

  • Participants with known hypersensitivity to iguratimod or any of its excipients

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aisai Aichi Japan
2 Ama Aichi Japan
3 Anjo Aichi Japan
4 Chita Aichi Japan
5 Gamagori Aichi Japan
6 Handa Aichi Japan
7 Hekinan Aichi Japan
8 Ichinomiya Aichi Japan
9 Kasugai Aichi Japan
10 Kitanagoya Aichi Japan
11 Nagakute Aichi Japan
12 Nagoya Aichi Japan
13 Okazaki Aichi Japan
14 Tokoname Aichi Japan
15 Toyohashi Aichi Japan
16 Toyokawa Aichi Japan
17 Toyota Aichi Japan
18 Tsushima Aichi Japan
19 Yatomi Aichi Japan
20 Minamiakita Akita Japan
21 Noshiro Akita Japan
22 Yurihonjo Akita Japan
23 Hachinohe Aomori Japan
24 Hirosaki Aomori Japan
25 Minamitsugaru Aomori Japan
26 Sannohe Aomori Japan
27 Abiko Chiba Japan
28 Awa Chiba Japan
29 Chosei Chiba Japan
30 Funabashi Chiba Japan
31 Ichihara Chiba Japan
32 Ichikawa Chiba Japan
33 Kashiwa Chiba Japan
34 Katori Chiba Japan
35 Kisarazu Chiba Japan
36 Matsudo Chiba Japan
37 Minamiboso Chiba Japan
38 Mobara Chiba Japan
39 Narashino Chiba Japan
40 Narita Chiba Japan
41 Sakura Chiba Japan
42 Sosa Chiba Japan
43 Tomisato Chiba Japan
44 Urayasu Chiba Japan
45 Yachiyo Chiba Japan
46 Yotsukaido Chiba Japan
47 Matsuyama Ehime Japan
48 Niihama Ehime Japan
49 Saijo Ehime Japan
50 Shikokuchuo Ehime Japan
51 Uwajima Ehime Japan
52 Mikatakaminaka Fukui Japan
53 Sabae Fukui Japan
54 Tsuruga Fukui Japan
55 Chikushi Fukuoka Japan
56 Fukutsu Fukuoka Japan
57 Itoshima Fukuoka Japan
58 Kasuga Fukuoka Japan
59 Kitakyushu Fukuoka Japan
60 Kurume Fukuoka Japan
61 Munakata Fukuoka Japan
62 Nakama Fukuoka Japan
63 Omuta Fukuoka Japan
64 Onga Fukuoka Japan
65 Yame Fukuoka Japan
66 Aizuwakamatsu Fukushima Japan
67 Iwaki Fukushima Japan
68 Koriyama Fukushima Japan
69 Shirakawa Fukushima Japan
70 Ibi Gifu Japan
71 Kakamigahara Gifu Japan
72 Kamo Gifu Japan
73 Motosu Gifu Japan
74 Nakatsugawa Gifu Japan
75 Ogaki Gifu Japan
76 Seki Gifu Japan
77 Yoro Gifu Japan
78 Agatsuma Gumma Japan
79 Annaka Gumma Japan
80 Fujioka Gumma Japan
81 Isesaki Gumma Japan
82 Kiryu Gumma Japan
83 Maebashi Gumma Japan
84 Ota Gumma Japan
85 Shibukawa Gumma Japan
86 Takasaki Gumma Japan
87 Akitakata Hiroshima Japan
88 Fukuyama Hiroshima Japan
89 Higashihiroshima Hiroshima Japan
90 Kure Hiroshima Japan
91 Onomichi Hiroshima Japan
92 Takehara Hiroshima Japan
93 Yamagata Hiroshima Japan
94 Abashiri Hokkaido Japan
95 Asahikawa Hokkaido Japan
96 Bibai Hokkaido Japan
97 Chitose Hokkaido Japan
98 Date Hokkaido Japan
99 Ebetsu Hokkaido Japan
100 Furano Hokkaido Japan
101 Hakodate Hokkaido Japan
102 Kitami Hokkaido Japan
103 Kushiro Hokkaido Japan
104 Matsumae Hokkaido Japan
105 Nayoro Hokkaido Japan
106 Obihiro Hokkaido Japan
107 Sapporo Hokkaido Japan
108 Shari Hokkaido Japan
109 Sorachi Hokkaido Japan
110 Takikawa Hokkaido Japan
111 Yoichi Hokkaido Japan
112 Ako Hyogo Japan
113 Amagasaki Hyogo Japan
114 Ashiya Hyogo Japan
115 Himeji Hyogo Japan
116 Kako Hyogo Japan
117 Kato Hyogo Japan
118 Kawanishi Hyogo Japan
119 Kobe Hyogo Japan
120 Miki Hyogo Japan
121 Minamiawaji Hyogo Japan
122 Nishinomiya Hyogo Japan
123 Ono Hyogo Japan
124 Sayo Hyogo Japan
125 Sumoto Hyogo Japan
126 Takarazuka Hyogo Japan
127 Takasago Hyogo Japan
128 Tamba Hyogo Japan
129 Tatsuno Hyogo Japan
130 Chikusei Ibaraki Japan
131 Higashiibaraki Ibaraki Japan
132 Hitachinaka Ibaraki Japan
133 Hitachi Ibaraki Japan
134 Inashiki Ibaraki Japan
135 Kasama Ibaraki Japan
136 Kashima Ibaraki Japan
137 Koga Ibaraki Japan
138 Mito Ibaraki Japan
139 Moriya Ibaraki Japan
140 Ryugasaki Ibaraki Japan
141 Toride Ibaraki Japan
142 Tsuchiura Ibaraki Japan
143 Tsukuba Ibaraki Japan
144 Yuki Ibaraki Japan
145 Hakui Ishikawa Japan
146 Kaga Ishikawa Japan
147 Kahoku Ishikawa Japan
148 Kanazawa Ishikawa Japan
149 Komatsu Ishikawa Japan
150 Hanamaki Iwate Japan
151 Ichinoseki Iwate Japan
152 Kitakami Iwate Japan
153 Morioka Iwate Japan
154 Ofunato Iwate Japan
155 Oshu Iwate Japan
156 Shimohei Iwate Japan
157 Ayauta Kagawa Japan
158 Kanonji Kagawa Japan
159 Marugame Kagawa Japan
160 Sakaide Kagawa Japan
161 Sanuki Kagawa Japan
162 Takamatsu Kagawa Japan
163 Akune Kagoshima Japan
164 Kanoya Kagoshima Japan
165 Oshima Kagoshima Japan
166 Soh Kagoshima Japan
167 Chigasaki Kanagawa Japan
168 Ebina Kanagawa Japan
169 Fujisawa Kanagawa Japan
170 Hiratsuka Kanagawa Japan
171 Isehara Kanagawa Japan
172 Kawasaki Kanagawa Japan
173 Sagamihara Kanagawa Japan
174 Yokohama Kanagawa Japan
175 Yokosuka Kanagawa Japan
176 Zushi Kanagawa Japan
177 Agawa Kochi Japan
178 Aki Kochi Japan
179 Kami Kochi Japan
180 Nankoku Kochi Japan
181 Shimanto Kochi Japan
182 Aso Kumamoto Japan
183 Hitoyoshi Kumamoto Japan
184 Kuma Kumamoto Japan
185 Minamata Kumamoto Japan
186 Tamana Kumamoto Japan
187 Yamaga Kumamoto Japan
188 Fukuchiyama Kyoto Japan
189 Joyo Kyoto Japan
190 Kameoka Kyoto Japan
191 Kizugawa Kyoto Japan
192 Kyotanabe Kyoto Japan
193 Maizuru Kyoto Japan
194 Nagaokakyo Kyoto Japan
195 Nantan Kyoto Japan
196 Soraku Kyoto Japan
197 Uji Kyoto Japan
198 Yawata Kyoto Japan
199 Kuwana Mie Japan
200 Matsusaka Mie Japan
201 Shima Mie Japan
202 Suzuka Mie Japan
203 Tsu Mie Japan
204 Yokkaichi Mie Japan
205 Higashimatsushima Miyagi Japan
206 Ishinomaki Miyagi Japan
207 Iwanuma Miyagi Japan
208 Kesennuma Miyagi Japan
209 Osaki Miyagi Japan
210 Sendai Miyagi Japan
211 Shibata Miyagi Japan
212 Hyuga Miyazaki Japan
213 Kobayashi Miyazaki Japan
214 Kushima Miyazaki Japan
215 Miyakonojo Miyazaki Japan
216 Saito Miyazaki Japan
217 Azumino Nagano Japan
218 Chiisagata Nagano Japan
219 Hanishina Nagano Japan
220 Iida Nagano Japan
221 Iiyama Nagano Japan
222 Ina Nagano Japan
223 Kamiminochi Nagano Japan
224 Komoro Nagano Japan
225 Matsumoto Nagano Japan
226 Okaya Nagano Japan
227 Saku Nagano Japan
228 Shimoina Nagano Japan
229 Shiojiri Nagano Japan
230 Suwa Nagano Japan
231 Ueda Nagano Japan
232 Omura Nagasaki Japan
233 Sasebo Nagasaki Japan
234 Kashiba Nara Japan
235 Kashihara Nara Japan
236 Kitakatsuragi Nara Japan
237 Shiki Nara Japan
238 Uda Nara Japan
239 Yamatokoriyama Nara Japan
240 Yamatotakada Nara Japan
241 Yoshino Nara Japan
242 Joetsu Niigata Japan
243 Kamo Niigata Japan
244 Sado Niigata Japan
245 Sanjo Niigata Japan
246 Shibata Niigata Japan
247 Beppu Oita Japan
248 Kunisaki Oita Japan
249 Nakatsu Oita Japan
250 Saiki Oita Japan
251 Yufu Oita Japan
252 Asakuchi Okayama Japan
253 Kurashiki Okayama Japan
254 Setouchi Okayama Japan
255 Tsukubo Okayama Japan
256 Naha Okinawa Japan
257 Tomigusuku Okinawa Japan
258 Urasoe Okinawa Japan
259 Daito Osaka Japan
260 Habikino Osaka Japan
261 Hannan Osaka Japan
262 Higashiosaka Osaka Japan
263 Hirakata Osaka Japan
264 Ibaraki Osaka Japan
265 Ikeda Osaka Japan
266 Izumiotsu Osaka Japan
267 Izumisano Osaka Japan
268 Kadoma Osaka Japan
269 Kaizuka Osaka Japan
270 Katano Osaka Japan
271 Kishiwada Osaka Japan
272 Mino Osaka Japan
273 Mishima Osaka Japan
274 Moriguchi Osaka Japan
275 Neyagawa Osaka Japan
276 Osakasayama Osaka Japan
277 Sakai Osaka Japan
278 Sennan Osaka Japan
279 Settsu Osaka Japan
280 Shijonawate Osaka Japan
281 Suita Osaka Japan
282 Takatsuki Osaka Japan
283 Toyonaka Osaka Japan
284 Ogi Saga Japan
285 Takeo Saga Japan
286 Taku Saga Japan
287 Tosu Saga Japan
288 Chichibu Saitama Japan
289 Fujimino Saitama Japan
290 Fujimi Saitama Japan
291 Fukaya Saitama Japan
292 Gyoda Saitama Japan
293 Hasuda Saitama Japan
294 Hidaka Saitama Japan
295 Higashimatsuyama Saitama Japan
296 Hiki Saitama Japan
297 Iruma Saitama Japan
298 Kasukabe Saitama Japan
299 Kawagoe Saitama Japan
300 Kawaguchi Saitama Japan
301 Kitakatsushika Saitama Japan
302 Kitamoto Saitama Japan
303 Koshigaya Saitama Japan
304 Kumagaya Saitama Japan
305 Minamisaitama Saitama Japan
306 Niiza Saitama Japan
307 Osato Saitama Japan
308 Satte Saitama Japan
309 Sayama Saitama Japan
310 Soka Saitama Japan
311 Tokorozawa Saitama Japan
312 Tsurugashima Saitama Japan
313 Wako Saitama Japan
314 Yashio Saitama Japan
315 Gamo Shiga Japan
316 Higashiomi Shiga Japan
317 Koka Shiga Japan
318 Kusatsu Shiga Japan
319 Moriyama Shiga Japan
320 Nagahama Shiga Japan
321 Otsu Shiga Japan
322 Izumo Shimane Japan
323 Matsue Shimane Japan
324 Oda Shimane Japan
325 Oki Shimane Japan
326 Yasugi Shimane Japan
327 Fujieda Shizuoka Japan
328 Fuji Shizuoka Japan
329 Gotemba Shizuoka Japan
330 Hamamatsu Shizuoka Japan
331 Izunokuni Shizuoka Japan
332 Kamo Shizuoka Japan
333 Mishima Shizuoka Japan
334 Numazu Shizuoka Japan
335 Syuchi Shizuoka Japan
336 Tagata Shizuoka Japan
337 Yaizu Shizuoka Japan
338 Ashikaga Tochigi Japan
339 Moka Tochigi Japan
340 Nasushiobara Tochigi Japan
341 Nikko Tochigi Japan
342 Oyama Tochigi Japan
343 Sano Tochigi Japan
344 Shimotsuke Tochigi Japan
345 Shioya Tochigi Japan
346 Utsunomiya Tochigi Japan
347 Anan Tokushima Japan
348 Itano Tokushima Japan
349 Miyoshi Tokushima Japan
350 Yoshinogawa Tokushima Japan
351 Adachi Tokyo Japan
352 Akiruno Tokyo Japan
353 Akishima Tokyo Japan
354 Arakawa Tokyo Japan
355 Bunkyo Tokyo Japan
356 Chiyoda Tokyo Japan
357 Chofu Tokyo Japan
358 Chuo Tokyo Japan
359 Edogawa Tokyo Japan
360 Fuchu Tokyo Japan
361 Hachioji Tokyo Japan
362 Higashikurume Tokyo Japan
363 Hino Tokyo Japan
364 Itabashi Tokyo Japan
365 Katsushika Tokyo Japan
366 Kita Tokyo Japan
367 Koganei Tokyo Japan
368 Kokubunji Tokyo Japan
369 Koto Tokyo Japan
370 Machida Tokyo Japan
371 Meguro Tokyo Japan
372 Minato Tokyo Japan
373 Mitaka Tokyo Japan
374 Musashimurayama Tokyo Japan
375 Musashino Tokyo Japan
376 Nakano Tokyo Japan
377 Nerima Tokyo Japan
378 Ome Tokyo Japan
379 Ota Tokyo Japan
380 Setagaya Tokyo Japan
381 Shibuya Tokyo Japan
382 Shinagawa Tokyo Japan
383 Shinjuku Tokyo Japan
384 Suginami Tokyo Japan
385 Sumida Tokyo Japan
386 Tachikawa Tokyo Japan
387 Taito Tokyo Japan
388 Tama Tokyo Japan
389 Toshima Tokyo Japan
390 Kurayoshi Tottori Japan
391 Sakaiminato Tottori Japan
392 Tohaku Tottori Japan
393 Yonago Tottori Japan
394 Himi Toyama Japan
395 Imizu Toyama Japan
396 Kurobe Toyama Japan
397 Nakaniikawa Toyama Japan
398 Nanto Toyama Japan
399 Oyabe Toyama Japan
400 Shimoniikawa Toyama Japan
401 Takaoka Toyama Japan
402 Tonami Toyama Japan
403 Arida Wakayama Japan
404 Nishimuro Wakayama Japan
405 Tanabe Wakayama Japan
406 Higashimurayama Yamagata Japan
407 Nishiokitama Yamagata Japan
408 Shinjo Yamagata Japan
409 Tendo Yamagata Japan
410 Tsuruoka Yamagata Japan
411 Yonezawa Yamagata Japan
412 Hofu Yamaguchi Japan
413 Nagato Yamaguchi Japan
414 Shimonoseki Yamaguchi Japan
415 Shunan Yamaguchi Japan
416 Ube Yamaguchi Japan
417 Chuo Yamanashi Japan
418 Fuefuki Yamanashi Japan
419 Kai Yamanashi Japan
420 Kofu Yamanashi Japan
421 Minamikoma Yamanashi Japan
422 Nirasaki Yamanashi Japan
423 Akita Japan
424 Aomori Japan
425 Chiba Japan
426 Fukui Japan
427 Fukuoka Japan
428 Fukushima Japan
429 Gifu Japan
430 Hiroshima Japan
431 Kagoshima Japan
432 Kochi Japan
433 Kumamoto Japan
434 Kyoto Japan
435 Miyagi Japan
436 Miyazaki Japan
437 Nagano Japan
438 Nagasaki Japan
439 Nara Japan
440 Niigata Japan
441 Oita Japan
442 Okayama Japan
443 Osaka Japan
444 Saga Japan
445 Saitama Japan
446 Shizuoka Japan
447 Tochigi Japan
448 Tokushima Japan
449 Tottori Japan
450 Toyama Japan
451 Wakayama Japan
452 Yamagata Japan
453 Yamaguchi Japan

Sponsors and Collaborators

  • Eisai Co., Ltd.

Investigators

  • Study Director: Akiko Yoshimura, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eisai Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01850966
Other Study ID Numbers:
  • CRM01T
First Posted:
May 10, 2013
Last Update Posted:
Nov 5, 2018
Last Verified:
Jan 1, 2017
Keywords provided by Eisai Co., Ltd.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2018