Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Biologic, Tumor Necrosis Factors blockers agents Monoclonal antibody
Brief summary
Adalimumab is one of the pharmacological treatments for rheumatoid arthritis (RA) of more recent marketing authorization, and as a result of this, there are only efficacy and safety data from clinical trials with controlled conditions.The study will evaluate the safety and effectiveness of adalimumab in the common clinical practice of RA treatment in Spain, with several types of patients showing concomitant treatments or diseases and compliance. Among the tumor necrosis factor antagonists safety studies, adalimumab safety has been the less investigated in the common clinical practice because of, as a result of its recent marketing, it was not included in the BIOBADASER (Data Base for Biological Products in Spain, Rheumatology Spanish Society), Biologic Products Database of the Spanish Society of Rheumatology ) in which was determined an association between infliximab therapy and the risk of developing active tuberculosis. To ensure the maintaining of the strict common physician practice (no prescription induction), and following the recommendations of the SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) consensus documents, it will be selected only those patients that were already in treatment with adalimumab (HUMIRA),(except patients involved in clinical studies with Adalimumab), and had shown good response, or those that fulfilled treatment indication in accordance with the SER recommendations and following the Summary of Products Characteristics of adalimumab (HUMIRA).
Detailed description
Main objective * To evaluate safety and tolerability of adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions. Secondary objectives * To evaluate the effectiveness of the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions in accordance with SER recommendations: * To evaluate the life quality associated to the adalimumab (HUMIRA) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis patients under usual practice conditions. * To describe the profile of patients who are in treatment with adalimumab (HUMIRA) biological therapy.
Interventions
BIOLOGICALadalimumab (HUMIRA®)
The primary objective of the study is to evaluate the safety and tolerability of adalimumab (HUMIRA®) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis (RA) patients under usual practice conditions.
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years * Patients who underwent adalimumab treatment at least for the previous 4 months before baseline visit, who have a good therapeutic response to treatment and have not been involved in previous clinical studies with Adalimumab or * Patients who previously to the baseline visit, have been prescribe adalimumab complying treatment indication according to SER (Sociedad Española de Reumatología, Spanish Society of Rheumatology) recommendations: * Patients who had provided informed consent. * Patients who have been prescribed adalimumab according to the Summary of Product Characteristics
Exclusion criteria
* Patients in whom a continued 12- months follow up is not anticipated. * The contraindications specified in the Summary of Products Characteristics * Hypersensibility to some of the components of the medication to administer. * Any pathology shown by the patient that, according to medical criterion, contraindicates the treatment indicated in the protocol according to the Summary of Products Characteristics of adalimumab (HUMIRA®).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | Baseline, 1, 4, 6, and 12 months | The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). | Baseline and 12 months | The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (\<= 2.6), Low Disease Activity (\>2.6 to \<=3.2), Moderate Disease Activity (\>3.2 to \<= 5.1) and High Disease Activity (\>5.1). The mean change in DAS 28 score from baseline to final is presented. |
| Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). | Baseline and 12 months | The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (\<= 2.6), Low Disease Activity (\>2.6 to \<=3.2), Moderate Disease Activity (\>3.2 to \<= 5.1) and High Disease Activity (\>5.1). The percentage reduction of baseline values is presented. |
| Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline. | Baseline and 12 months | Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: \<1 = no/mild disability, 1 to 2 = moderate disability, and \>2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value). |
| Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline. | Baseline and 12 Months | Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: \<1 = no/mild disability, 1 to 2 = moderate disability, and \>2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented. |
| Radiological Evaluation of Rheumatoid Arthritis (RA). | Baseline and 12 months | Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup. |
| Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | Baseline, 1, 4, 6, and 12 months | The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab (Humira) | 591 |
| Total | 591 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 36 |
| Overall Study | Lack of effectiveness | 36 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Reason not reported | 21 |
| Overall Study | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Adalimumab (Humira) |
|---|---|
| Age Continuous | 54.15 years STANDARD_DEVIATION 12.43 |
| Positivity of the Rheumatoid Factor Negative for Rheumatoid Factor | 114 participants |
| Positivity of the Rheumatoid Factor Positive for Rheumatoid Factor | 460 participants |
| Positivity of the Rheumatoid Factor Rheumatoid Factor Results Unknown or Missing | 17 participants |
| Previous Rheumatoid Arthritis Treatment Had previous rheumatoid arthritis treatment | 588 participants |
| Previous Rheumatoid Arthritis Treatment No previous rheumatoid arthritis treatment | 3 participants |
| Region of Enrollment Spain | 591 participants |
| Sex/Gender, Customized Female | 461 participants |
| Sex/Gender, Customized Gender not reported | 3 participants |
| Sex/Gender, Customized Male | 127 participants |
| Time from Diagnosis of Rheumatoid Arthritis | 8.56 Years STANDARD_DEVIATION 6.86 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 675 |
| serious Total, serious adverse events | 28 / 675 |
Outcome results
Primary
Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment
The safety and tolerability of adalimumab was assessed at each study visit. The overall number of participants experiencing serious adverse events (SAEs), non-serious adverse events (AEs) and AEs that led to discontinuation are presented. The number of participants presenting with any serious or non-serious event at each particular study visit is also reported. Note that for the incidence data participants were counted multiple times if they experienced an adverse event at more than 1 visit. For additional information see Reported Adverse Events.
Time frame: Baseline, 1, 4, 6, and 12 months
Population: This analysis was performed in the safety population of all participants who took at least 1 dose of adalimumab (675 participants).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | Overall: Experienced a serious adverse event | 28 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | Overall: Experienced a non-serious AE | 184 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | Overall: Discontinued from study due to an AE | 36 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | Incidence: At least 1 AE at Baseline | 53 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 AE at 1 month | 49 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 AE at 4 months | 50 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 AE at 6 months | 47 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 AE at 12 months | 51 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | Incidence: At least 1 SAE at Baseline | 4 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 SAE at 1 month | 4 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 SAE at 4 months | 6 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 SAE at 6 months | 6 Participants |
| Adalimumab Treatment | Safety and Tolerability of Adalimumab Treatment. Adverse Events: Medical Occurrence in a Patient or Clinical Investigation Subject Administered a Pharmaceutical Product and Which Does Not Necessarily Have a Causal Relationship With the Treatment | -- Incidence: At least 1 SAE at 12 months | 8 Participants |
Secondary
Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits.
The treating physician was to clinically assess each participant at each study visit and report the number of painful and swollen joints. The mean number of painful or swollen joints for participants evaluated at each time point are presented by subgroup. The number of participants evaluated in each subgroup at each time point are also reported.
Time frame: Baseline, 1, 4, 6, and 12 months
Population: This analysis was conducted in the ITT population of 591 participants who had assessments at each time point. The number of de novo participants and participants treated greater than 4 months who were analyzed at each time point are given in parentheses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | Painful Joints at Baseline (n=310 and n =281) | 7.93 Joints | Standard Deviation 6.31 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 1 month (n=277 and n=203) | 4.11 Joints | Standard Deviation 5.13 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 4 months (n=292 and n=271) | 2.99 Joints | Standard Deviation 4.14 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 6 months (n=269 and n=267) | 2.53 Joints | Standard Deviation 3.42 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 12 months (n=255 and n=262) | 2.46 Joints | Standard Deviation 3.33 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | Swollen Joints at Baseline (n=310 and n=281) | 6.19 Joints | Standard Deviation 5.01 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 1 month (n=277 and n= 204) | 2.94 Joints | Standard Deviation 3.89 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 4 months (n=292 and n=272) | 2.33 Joints | Standard Deviation 3.39 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 6 months (n=269 and n=266) | 2.53 Joints | Standard Deviation 3.42 |
| Adalimumab Treatment | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 12 months (n=255 and n=262) | 1.73 Joints | Standard Deviation 2.83 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 4 months (n=292 and n=272) | 1.04 Joints | Standard Deviation 2.1 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | Painful Joints at Baseline (n=310 and n =281) | 2.22 Joints | Standard Deviation 3.39 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | Swollen Joints at Baseline (n=310 and n=281) | 1.39 Joints | Standard Deviation 2.41 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 1 month (n=277 and n=203) | 1.67 Joints | Standard Deviation 3.07 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 12 months (n=255 and n=262) | 0.97 Joints | Standard Deviation 2 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 4 months (n=292 and n=271) | 1.76 Joints | Standard Deviation 2.99 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 1 month (n=277 and n= 204) | 1.03 Joints | Standard Deviation 2.16 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 6 months (n=269 and n=267) | 1.71 Joints | Standard Deviation 2.86 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 6 months (n=269 and n=266) | 1.00 Joints | Standard Deviation 2.02 |
| Adalimumab (Treated for Greater Than 4 Months) | Clinical Evaluation of Rheumatoid Arthritis (RA). Clinical Evaluation in the Inclusion Visit and in Each One of the Study Visits. | -- At 12 months (n=255 and n=262) | 1.61 Joints | Standard Deviation 3.03 |
Secondary
Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (\<= 2.6), Low Disease Activity (\>2.6 to \<=3.2), Moderate Disease Activity (\>3.2 to \<= 5.1) and High Disease Activity (\>5.1). The mean change in DAS 28 score from baseline to final is presented.
Time frame: Baseline and 12 months
Population: Mean change from baseline to 12 months included the ITT population of 310 de novo and 281 participants treated greater than 4 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab Treatment | Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). | 1.62 Units on a scale | Standard Deviation 1.61 |
| Adalimumab (Treated for Greater Than 4 Months) | Disease Activity Score (DAS 28) Index Mean Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). | 0.21 Units on a scale | Standard Deviation 1.23 |
Secondary
Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA).
The DAS 28 index measures disease activity in rheumatoid arthritis and is derived from the number swollen/tender joints, laboratory tests of inflammation, and participant assessment of global health (by marking a 10 cm line from very good to very bad). Ranges were used to classify participants, with a higher score indicating worse control of disease: Remission (\<= 2.6), Low Disease Activity (\>2.6 to \<=3.2), Moderate Disease Activity (\>3.2 to \<= 5.1) and High Disease Activity (\>5.1). The percentage reduction of baseline values is presented.
Time frame: Baseline and 12 months
Population: Mean reduction from baseline to 12 months was calculated for the ITT population of 310 de novo and 279 participants treated greater than 4 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab Treatment | Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). | 0.28 Percentage reduction | Standard Deviation 0.34 |
| Adalimumab (Treated for Greater Than 4 Months) | Disease Activity Score (DAS 28) Index Percentage Change From Baseline. The Disease Activity Score (DAS) is a Combined Index That Has Been Developed to Measure the Disease Activity in Patients With Rheumatoid Arthritis (RA). | 0.01 Percentage reduction | Standard Deviation 0.42 |
Secondary
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline.
Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: \<1 = no/mild disability, 1 to 2 = moderate disability, and \>2 = severe disability. An increased score indicates a worsening of the disability. The mean change in global HAQ score from baseline to 12 months is reported (baseline value - final value).
Time frame: Baseline and 12 months
Population: The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab Treatment | Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline. | 0.44 Units on a scale | Standard Deviation 0.67 |
| Adalimumab (Treated for Greater Than 4 Months) | Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Mean Change From Baseline. | 0.05 Units on a scale | Standard Deviation 0.48 |
Secondary
Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline.
Quality of life was assessed using the Health Assessment Questionnaire (HAQ). The HAQ is a self-reported scale used in studies of rheumatoid arthritis to assess areas such as dressing/grooming arising, eating, walking, reach, grip, maintaining hygiene, and daily activities. The global HAQ questionnaire was scored as follows: \<1 = no/mild disability, 1 to 2 = moderate disability, and \>2 = severe disability. An increased score indicates a worsening of the disability. The percentage change from baseline to 12 months (12-month score minus baseline score divided by baseline score) is presented.
Time frame: Baseline and 12 Months
Population: The analysis was conducted for participants who had both baseline and 12-month global HAQ assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adalimumab Treatment | Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline. | 0.25 Percentage change | Standard Deviation 0.79 |
| Adalimumab (Treated for Greater Than 4 Months) | Life Quality Assessment Health Assessment Questionnaire (HAQ Questionnaire) Percentage Change From Baseline. | -0.09 Percentage change | Standard Deviation 1.54 |
Secondary
Radiological Evaluation of Rheumatoid Arthritis (RA).
Treating physicians were asked to obtain a structural damage assessment by performing x-rays of the hands and feet approximately 1 year after the previous structural damage assessment that was done prior to the participant entering the study. The number of participants with radiological erosions evaluated at baseline and the 12-month visit are summarized by subgroup.
Time frame: Baseline and 12 months
Population: This analysis was conducted in the intent-to-treat population (591 participants total).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | a) Radiological erosions present | 153 Participant |
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | Total evaluated or not reported at 12 months | 310 Participant |
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | Total number evaluated or not reported at Baseline | 310 Participant |
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | a) Radiological erosions present | 58 Participant |
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | b) Radiological erosions not present | 49 Participant |
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | b) Radiological erosions not present | 75 Participant |
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | c) Radiological erosions unknown | 135 Participant |
| Adalimumab Treatment | Radiological Evaluation of Rheumatoid Arthritis (RA). | c) Radiological erosions unknown | 54 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | c) Radiological erosions unknown | 97 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | b) Radiological erosions not present | 57 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | Total number evaluated or not reported at Baseline | 281 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | a) Radiological erosions present | 156 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | c) Radiological erosions unknown | 50 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | Total evaluated or not reported at 12 months | 281 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | b) Radiological erosions not present | 45 Participant |
| Adalimumab (Treated for Greater Than 4 Months) | Radiological Evaluation of Rheumatoid Arthritis (RA). | a) Radiological erosions present | 97 Participant |