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A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis

2012. augusztus 1. frissítette: Abbott

A Phase 3 Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Comparing Adalimumab and Placebo in Adult Japanese Subjects With Rheumatoid Arthritis

To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.

A tanulmány áttekintése

Részletes leírás

This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo in adult Japanese patients with early rheumatoid arthritis (RA) who had not been previously treated with methotrexate (MTX). Eligible participants were randomized 1:1 to receive either a subcutaneous injection of adalimumab 40 mg or matching placebo every other week (eow) during the 26-week double-blind phase. All participants also received 6 mg to 8 mg MTX weekly as basal treatment for their disease. Participants who experienced an increase in disease activity (more than 20% increase in tender joint count and swollen joint count) at Week 12, 16, or 20 compared with Baseline after having increased MTX dose to 8 mg per week for at least 4 weeks were discontinued from the double-blind phase and were eligible to receive open-label adalimumab 40 mg eow as rescue treatment. Participants who completed the 26 weeks of treatment (either double-blind study drug [adalimumab or placebo] treatment or open-label adalimumab treatment) were eligible to enter the 26-week open-label phase in which they received adalimumab 40 mg eow. Efficacy and safety assessments were performed at Baseline and at designated study visits.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

334

Fázis

  • 3. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

      • Anjo, Japán
        • Site Reference ID/Investigator# 46861
      • Aomori, Japán
        • Site Reference ID/Investigator# 46919
      • Chiba, Japán
        • Site Reference ID/Investigator# 46805
      • Chiba, Japán
        • Site Reference ID/Investigator# 46806
      • Chiba, Japán
        • Site Reference ID/Investigator# 46880
      • Chiba, Japán
        • Site Reference ID/Investigator# 46881
      • Fuchu, Japán
        • Site Reference ID/Investigator# 46890
      • Fukuoka, Japán
        • Site Reference ID/Investigator# 46902
      • Fukuoka, Japán
        • Site Reference ID/Investigator# 46903
      • Fukuoka, Japán
        • Site Reference ID/Investigator# 46904
      • Gifu, Japán
        • Site Reference ID/Investigator# 46856
      • Gunma, Japán
        • Site Reference ID/Investigator# 46944
      • Hiroshima, Japán
        • Site Reference ID/Investigator# 46893
      • Hiroshima, Japán
        • Site Reference ID/Investigator# 46894
      • Hokkaido, Japán
        • Site Reference ID/Investigator# 12161
      • Hokkaido, Japán
        • Site Reference ID/Investigator# 46916
      • Hokkaido, Japán
        • Site Reference ID/Investigator# 46918
      • Hyogo, Japán
        • Site Reference ID/Investigator# 46865
      • Hyogo, Japán
        • Site Reference ID/Investigator# 46871
      • Ibaraki, Japán
        • Site Reference ID/Investigator# 46801
      • Ibaraki, Japán
        • Site Reference ID/Investigator# 46925
      • Iwate, Japán
        • Site Reference ID/Investigator# 46800
      • Kagoshima, Japán
        • Site Reference ID/Investigator# 46873
      • Kagoshima, Japán
        • Site Reference ID/Investigator# 46874
      • Kanagawa, Japán
        • Site Reference ID/Investigator# 46845
      • Kanagawa, Japán
        • Site Reference ID/Investigator# 46899
      • Kanagawa, Japán
        • Site Reference ID/Investigator# 46901
      • Kanazawa, Japán
        • Site Reference ID/Investigator# 46851
      • Kanazawa, Japán
        • Site Reference ID/Investigator# 46852
      • Kawagoe, Japán
        • Site Reference ID/Investigator# 46802
      • Kawasaki, Japán
        • Site Reference ID/Investigator# 46900
      • Kirishima, Japán
        • Site Reference ID/Investigator# 46875
      • Kitakyushu, Japán
        • Site Reference ID/Investigator# 46870
      • Kumamoto, Japán
        • Site Reference ID/Investigator# 46872
      • Kumamoto, Japán
        • Site Reference ID/Investigator# 46912
      • Kyoto, Japán
        • Site Reference ID/Investigator# 46864
      • Maebashi, Japán
        • Site Reference ID/Investigator# 46943
      • Matsuyama, Japán
        • Site Reference ID/Investigator# 46898
      • Miyazaki, Japán
        • Site Reference ID/Investigator# 46915
      • Nagano, Japán
        • Site Reference ID/Investigator# 46853
      • Nagano, Japán
        • Site Reference ID/Investigator# 46855
      • Nagasaki, Japán
        • Site Reference ID/Investigator# 46909
      • Nagasaki, Japán
        • Site Reference ID/Investigator# 46910
      • Nagasaki, Japán
        • Site Reference ID/Investigator# 46911
      • Nagoya, Japán
        • Site Reference ID/Investigator# 46858
      • Nagoya, Japán
        • Site Reference ID/Investigator# 46860
      • Nara, Japán
        • Site Reference ID/Investigator# 46877
      • Nara, Japán
        • Site Reference ID/Investigator# 46885
      • Niigata, Japán
        • Site Reference ID/Investigator# 46848
      • Niigata, Japán
        • Site Reference ID/Investigator# 46906
      • Oita, Japán
        • Site Reference ID/Investigator# 46914
      • Okayama, Japán
        • Site Reference ID/Investigator# 46869
      • Okayama, Japán
        • Site Reference ID/Investigator# 46886
      • Okayama, Japán
        • Site Reference ID/Investigator# 46887
      • Okayama, Japán
        • Site Reference ID/Investigator# 46892
      • Okinawa, Japán
        • Site Reference ID/Investigator# 46876
      • Osaka, Japán
        • Site Reference ID/Investigator# 46946
      • Osaka, Japán
        • Site Reference ID/Investigator# 46947
      • Rifu, Japán
        • Site Reference ID/Investigator# 46842
      • Sagamihara, Japán
        • Site Reference ID/Investigator# 46846
      • Saitama, Japán
        • Site Reference ID/Investigator# 46803
      • Saitama, Japán
        • Site Reference ID/Investigator# 46804
      • Saitama, Japán
        • Site Reference ID/Investigator# 46878
      • Saitama, Japán
        • Site Reference ID/Investigator# 46879
      • Sapporo, Japán
        • Site Reference ID/Investigator# 46917
      • Shimotsuke, Japán
        • Site Reference ID/Investigator# 46942
      • Shizuoka, Japán
        • Site Reference ID/Investigator# 46854
      • Shizuoka, Japán
        • Site Reference ID/Investigator# 46857
      • Shizuoka, Japán
        • Site Reference ID/Investigator# 46859
      • Takamatsu, Japán
        • Site Reference ID/Investigator# 46895
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46843
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46844
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46850
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46882
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46883
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46884
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46888
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46889
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46891
      • Tokyo, Japán
        • Site Reference ID/Investigator# 46896
      • Toyama, Japán
        • Site Reference ID/Investigator# 46849
      • Toyama, Japán
        • Site Reference ID/Investigator# 46907
      • Toyoake, Japán
        • Site Reference ID/Investigator# 46862
      • Toyohashi, Japán
        • Site Reference ID/Investigator# 46866
      • Tsu, Japán
        • Site Reference ID/Investigator# 46863
      • Tsukuba, Japán
        • Site Reference ID/Investigator# 46926
      • Yokohama, Japán
        • Site Reference ID/Investigator# 46897
      • Yokohama, Japán
        • Site Reference ID/Investigator# 46905

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

20 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria

  • Rheumatoid arthritis based on the American College of Rheumatology criteria
  • Methotrexate or leflunomide naïve
  • Disease duration less than or equal to 2 years from diagnosis

Exclusion Criteria

  • History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
  • Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
  • Joint surgery involving joints to be assessed within 8 weeks prior to Screening

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Négyszeres

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Placebo Comparator: DB Placebo
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Más nevek:
  • Placebo
Kísérleti: DB adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Más nevek:
  • ABT-D2E7, adalimumab, Humira
Kísérleti: DB Adalimumab/OL Adalimumab
Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Más nevek:
  • ABT-D2E7, adalimumab, Humira
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Más nevek:
  • adalimumab
  • ABT-D2E7
  • Humira
Kísérleti: DB Placebo/OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Más nevek:
  • Placebo
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Más nevek:
  • adalimumab
  • ABT-D2E7
  • Humira
Kísérleti: DB Adalimumab/RE OL Adalimumab
Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow)
Más nevek:
  • ABT-D2E7, adalimumab, Humira
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Más nevek:
  • adalimumab
  • ABT-D2E7
  • Humira
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
Más nevek:
  • adalimumab
  • ABT-D2E7
  • Humira
Kísérleti: DB Placebo/RE OL Adalimumab
Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow)
Más nevek:
  • Placebo
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study
Más nevek:
  • adalimumab
  • ABT-D2E7
  • Humira
Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
Más nevek:
  • adalimumab
  • ABT-D2E7
  • Humira

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change From Baseline in Modified Total Sharp X-Ray Score at Week 26
Időkeret: Baseline, Week 26
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 26

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Number of Participants Meeting ACR20 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Időkeret: Week 26
Patients were ACR20 responders if they had: >= 20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR50 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Időkeret: Week 26
Patients were ACR50 responders if they had: >= 50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Number of Participants Meeting ACR70 Response Criteria at Week 26 (ACR: American College of Rheumatology)
Időkeret: Week 26
Patients were ACR70 responders if they had: >= 70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant C-reactive protein. Patients who discontinued or switched to open-label adalimumab prior to Week 26 were considered non-responders.
Week 26
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 26
Időkeret: Baseline, Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 26
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 26
Időkeret: Week 26
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 26
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) on Double-blind Study Drug Through Week 26
Időkeret: Through Week 26
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of study drug. The number of participants who experienced any adverse event (serious or non-serious) while receiving double-blind study drug is summarized. See the Reported Adverse Event section for details.
Through Week 26
Change From Baseline in Modified Total Sharp X-Ray Score at Week 52
Időkeret: Baseline, Week 52
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Scores were added, giving total mTSS score (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates diseae progression; small positive/no change indicates slowing/halting of disease progression.
Baseline, Week 52
Number of Participants Meeting ACR20 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Időkeret: Week 52
Patients were ACR20 responders if they had: >=20% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=20% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR50 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Időkeret: Week 52
Patients were ACR50 responders if they had: >=50% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=50% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Number of Participants Meeting ACR70 Response Criteria at Week 52 (ACR: American College of Rheumatology)
Időkeret: Week 52
Patients were ACR70 responders if they had: >=70% improvement in both tender joint count (68 joints) and in swollen joint count (66 joints) plus >=70% improvement in at least 3 of the 5 remaining ACR core measures: patient's assessment of pain; patient's global assessment of disease activity; physician's global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire (HAQ); and acute phase reactant C-reactive protein.
Week 52
Change From Baseline in Disease Activity Score (DAS28[ESR]) at Week 52
Időkeret: Baseline, Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
Baseline, Week 52
Number of Participants Achieving Clinical Remission, Defined by Disease Activity Score (DAS28[ESR]) <2.6, at Week 52
Időkeret: Week 52
Disease Activity Score (DAS28) is a combined index used to measure disease activity in patients with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate. DAS28(ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity. DAS28(ESR) score <2.6 was defined as clinical remission of disease.
Week 52
Number of Participants Who Reported Any Adverse Event (Serious or Non-serious) While Receiving Adalimumab Through Week 52
Időkeret: Through Week 52
Adverse events were collected at designated study visits for all participants who were randomized and received at least 1 dose of adalimumab. The number of participants who experienced any adverse event (serious or non-serious) while receiving any adalimumab during the study (double-blind adalimumab and/or open-label) is summarized. See the Reported Adverse Event section for details.
Through Week 52

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Együttműködők

Nyomozók

  • Tanulmányi igazgató: Hiroshi Ukai, BS, Abbott Japan Co.,Ltd

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2009. március 1.

Elsődleges befejezés (Tényleges)

2011. március 1.

A tanulmány befejezése (Tényleges)

2011. augusztus 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2009. március 26.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2009. március 26.

Első közzététel (Becslés)

2009. március 27.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2012. augusztus 7.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2012. augusztus 1.

Utolsó ellenőrzés

2012. augusztus 1.

Több információ

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Rheumatoid arthritis

3
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