An observational study in Rheumatoid Arthritis, sponsored by AbbVie (prior sponsor, Abbott). Completed at 60 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-26.
Sponsored by AbbVie (prior sponsor, Abbott) · Observational
The objectives of the study are to observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization and to observe compliance of patients with the prescribed treatment.
This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.
Once the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up with the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data, if they are part of clinical routine, will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's enrollment of 566 is above the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 223 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Rheumatoid Arthritis on Humira (adalimimab) treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.
Time frame: 3 years
Disease Activity Score (DAS) 28 Over Time
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
European League Against Rheumatism (EULAR) Response
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of \> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. A Moderate EULAR Response is defined as either: * an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or * an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. No Response is defined as either: * an improvement (decrease) in the DAS28 of ≤ to 0.6, or * an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1.
Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Participants With an American College of Rheumatology (ACR) 20 Response
American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Participants With an American College of Rheumatology (ACR) 50 Response
American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Number of Participants With an American College of Rheumatology (ACR) 70 Response
American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 70% improvement in tender joint count; * ≥ 70% improvement in swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
Time frame: Baseline and Months 3, 6, 9, 12, 18, 24, 30, and 36
Percentage of Participants Who Missed at Least One Dose of Humira
Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.
Time frame: Months 3, 6, 9, 12, 18, 24, 30, and 36
| Milestone | Humira |
|---|---|
| Started | 566 |
| Completed | 262 |
| Not completed | 304 |
| Withdrew: Lack of efficacy/exacerbation of ra | 86 |
| Withdrew: Lost to follow-up | 86 |
| Withdrew: Adverse event | 42 |
| Withdrew: Withdrawal by subject | 41 |
| Withdrew: Other | 14 |
| Withdrew: Other | 13 |
| Withdrew: Ae and withdrew consent | 5 |
| Withdrew: Withdrew consent and lack of efficacy | 5 |
| Withdrew: Withdrew consent and other reason | 4 |
| Withdrew: Ae and lack of efficacy | 4 |
| Withdrew: Death | 1 |
| Withdrew: Ae and lost to follow-up | 1 |
| Withdrew: Ae and other reason | 1 |
| Withdrew: Ae, withdrew consent & lack of efficacy | 1 |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): Results in death, is life-threatening, results in hospitalization or the prolongation of hospitalization, is a congenital anomaly or a persistent or significant disability/incapacity, is an event that results in a condition that substantially interferes with the activities of daily living of the participant, is an important medical event requiring medical or surgical intervention to prevent a serious outcome, spontaneous abortion or miscarriage experienced by the participant, or an elective abortion performed on the participant.
| participants | Humira |
|---|---|
| Any Adverse Event | 262 |
| Serious Adverse Event | 65 |
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
| units on a scale | Humira |
|---|---|
| Baseline (n=555) | 6.0 ± 1.2 |
| Month 3 (n=510) | 4.2 ± 1.4 |
| Month 6 (n=449) | 3.8 ± 1.5 |
| Month 9 (n=401) | 3.5 ± 1.5 |
| Month 12 (n=379) | 3.5 ± 1.5 |
| Month 18 (n=333) | 3.3 ± 1.5 |
| Month 24 (n=298) | 3.2 ± 1.5 |
| Month 30 (n=264) | 3.0 ± 1.4 |
| Month 36 (n=254) | 2.9 ± 1.4 |
A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good EULAR Response is defined as an improvement (decrease) in the DAS28 of \> 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2. A Moderate EULAR Response is defined as either: * an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1, or * an improvement (decrease) in the DAS28 of \> 1.2 from Baseline and attainment of a DAS28 score of \> 3.2. No Response is defined as either: * an improvement (decrease) in the DAS28 of ≤ to 0.6, or * an improvement (decrease) in the DAS28 of \> 0.6 and ≤ 1.2 and attainment of a DAS28 of \> 5.1.
| participants | Good Response | Moderate Response | No Response |
|---|---|---|---|
| Month 3 (n=501) | 112 | 242 | 147 |
| Month 6 (n=443) | 154 | 193 | 96 |
| Month 9 (n=394) | 173 | 147 | 74 |
| Month 12 (n=373) | 171 | 139 | 63 |
| Month 18 (n=327) | 168 | 105 | 54 |
| Month 24 (n=294) | 169 | 84 | 41 |
| Month 30 (n=262) | 155 | 78 | 29 |
| Month 36 (n=253) | 156 | 68 | 29 |
American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
| participants | Humira |
|---|---|
| Month 3 (n=491) | 265 |
| Month 6 (n=427) | 279 |
| Month 9 (n=384) | 263 |
| Month 12 (n=363) | 248 |
| Month 18 (n=330) | 241 |
| Month 24 (n=293) | 216 |
| Month 30 (n=259) | 198 |
| Month 36 (n=248) | 194 |
American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
| participants | Humira |
|---|---|
| Month 3 (n=498) | 134 |
| Month 6 (n=433) | 188 |
| Month 9 (n=388) | 205 |
| Month 12 (n=368) | 182 |
| Month 18 (n=333) | 184 |
| Month 24 (n=291) | 170 |
| Month 30 (n=256) | 161 |
| Month 36 (n=250) | 164 |
American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 70% improvement in tender joint count; * ≥ 70% improvement in swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a 100 mm VAS); * Physician's global assessment of disease activity (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * Acute phase reactant value (C-reactive protein \[CRP\]).
| participants | Humira |
|---|---|
| Month 3 (n=495) | 67 |
| Month 6 (n=435) | 118 |
| Month 9 (n=390) | 147 |
| Month 12 (n=373) | 142 |
| Month 18 (n=330) | 154 |
| Month 24 (n=294) | 149 |
| Month 30 (n=261) | 139 |
| Month 36 (n=253) | 144 |
Compliance to study treatment was measured by the percentage of participants who missed at least one dose of Humira during each time interval between study visits.
| percentage of participants | Humira |
|---|---|
| Month 3 (n=512) | 6.6 |
| Month 6 (n=451) | 8.6 |
| Month 9 (n=406) | 7.4 |
| Month 12 (n=384) | 7.3 |
| Month 18 (n=341) | 8.2 |
| Month 24 (n=303) | 7.6 |
| Month 30 (n=271) | 5.5 |
| Month 36 (n=262) | 4.2 |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Humira | — | 65/566 (11.5%) | 109/566 (19.3%) |
| Event | Humira |
|---|---|
| Fever/PyrexiaGeneral disorders | 7/566 |
| FallInjury, poisoning and procedural complications | 5/566 |
| Weakness/AstheniaGeneral disorders | 4/566 |
| RA flare upMusculoskeletal and connective tissue disorders | 4/566 |
| Abdominal painGastrointestinal disorders | 3/566 |
| Respiratory tract infectionInfections and infestations | 3/566 |
| AnemiaBlood and lymphatic system disorders | 2/566 |
| Acute myocardial infarction/Myocardial infarctionCardiac disorders | 2/566 |
| DiarrheaGastrointestinal disorders | 2/566 |
| FatigueGeneral disorders | 2/566 |
| Event | Humira |
|---|---|
| Drug ineffectiveGeneral disorders | 91/566 |
| Respiratory infectionInfections and infestations | 35/566 |
| Age Continuous(years) | Humira |
|---|---|
| Mean | 56.8 ± 13.2 |
| Sex: Female, Male(Participants) | Humira |
|---|---|
| Female | 456 |
| Male | 110 |
| Region of Enrollment(participants) | Humira |
|---|---|
| Greece | 566 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott) →