Trial Outcomes & Findings for Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents (NCT NCT01783730)

NCT ID: NCT01783730

Last Updated: 2016-10-26

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.

• Recruitment status: COMPLETED
• Target enrollment: 163 participants
• Primary outcome timeframe: From baseline through week 26
• Results posted on: 2016-10-26

Participant Flow

Participants who received adalimumab treatment

Participant milestones

Measure	Participants With High Rheumatoid Arthritis Disease Activity Participants who received adalimumab treatment
Overall Study STARTED	163
Overall Study COMPLETED	157
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Participants With High Rheumatoid Arthritis Disease Activity Participants who received adalimumab treatment
Overall Study Failed to meet inclusion criteria	6

Baseline Characteristics

Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

Baseline characteristics by cohort

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=157 Participants Participants who received adalimumab treatment
Age, Continuous	56.5 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	103 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline through week 26

Population: Participants who received adalimumab treatment

An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=157 Participants Participants who received adalimumab treatment
Number of Participants With Adverse Events	40 participants

SECONDARY outcome

Timeframe: at week 0

Population: Participants with available data

The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=121 Participants Participants who received adalimumab treatment
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline	5.61 units on a scale Standard Deviation 1.39

SECONDARY outcome

Timeframe: at week 4

Population: Participants with available data

The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 .

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=107 Participants Participants who received adalimumab treatment
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4	3.57 units on a scale Standard Deviation 1.52

SECONDARY outcome

Timeframe: at week 12

Population: Participants with available data

The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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 .

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=90 Participants Participants who received adalimumab treatment
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12	2.96 units on a scale Standard Deviation 1.35

SECONDARY outcome

Timeframe: at week 24

Population: Participants with available data

The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=79 Participants Participants who received adalimumab treatment
Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24	2.41 units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: From baseline to 24 weeks

Population: Participants with available data

The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were 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. The percentage of participants with a DAS28 score <2.6 was documented.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=131 Participants Participants who received adalimumab treatment
Percentage of Participants Achieving DAS28-4(ESR) Remission Baseline, n=121	0.0 percentage of participants
Percentage of Participants Achieving DAS28-4(ESR) Remission Week 4, n=107	29.9 percentage of participants
Percentage of Participants Achieving DAS28-4(ESR) Remission Week 12, n=90	45.6 percentage of participants
Percentage of Participants Achieving DAS28-4(ESR) Remission Week 24, n=79	60.8 percentage of participants

SECONDARY outcome

Timeframe: at week 0

Population: Participants with available data

The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=138 Participants Participants who received adalimumab treatment
Mean Clinical Disease Activity Index (CDAI) Score at Baseline	29.18 units on a scale Standard Deviation 14.38

SECONDARY outcome

Timeframe: at week 4

Population: Participants with available data

The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=130 Participants Participants who received adalimumab treatment
Mean Clinical Disease Activity Index (CDAI) Score at Week 4	10.95 units on a scale Standard Deviation 9.30

SECONDARY outcome

Timeframe: at week 12

Population: Participants with available data

The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=108 Participants Participants who received adalimumab treatment
Mean Clinical Disease Activity Index (CDAI) Score at Week 12	7.26 units on a scale Standard Deviation 7.73

SECONDARY outcome

Timeframe: at week 24

Population: Participants with available data

The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=88 Participants Participants who received adalimumab treatment
Mean Clinical Disease Activity Index (CDAI) Score at Week 24	3.96 units on a scale Standard Deviation 4.39

SECONDARY outcome

Timeframe: From baseline to 24 weeks

Population: Participants with available data

The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. The percentage of participants with a CDAI score ≤2.8 was documented.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=146 Participants Participants who received adalimumab treatment
Percentage of Participants Achieving CDAI Remission Baseline, n=138	0.7 percentage of participants
Percentage of Participants Achieving CDAI Remission Week 4, n=130	20.0 percentage of participants
Percentage of Participants Achieving CDAI Remission Week 12, n=108	35.2 percentage of participants
Percentage of Participants Achieving CDAI Remission Week 24, n=88	60.2 percentage of participants

SECONDARY outcome

Timeframe: at week 0

Population: Participants with available data

The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=131 Participants Participants who received adalimumab treatment
Mean Simplified Disease Activity Index (SDAI) Score at Baseline	32.30 units on a scale Standard Deviation 16.07

SECONDARY outcome

Timeframe: at week 4

Population: Participants with available data

The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=123 Participants Participants who received adalimumab treatment
Mean Simplified Disease Activity Index (SDAI) Score at Week 4	12.06 units on a scale Standard Deviation 10.20

SECONDARY outcome

Timeframe: at week 12

Population: Participants with available data

The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=103 Participants Participants who received adalimumab treatment
Mean Simplified Disease Activity Index (SDAI) Score at Week 12	8.08 units on a scale Standard Deviation 9.09

SECONDARY outcome

Timeframe: at week 24

Population: Participants with available data

The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=85 Participants Participants who received adalimumab treatment
Mean Simplified Disease Activity Index (SDAI) Score at Week 24	4.58 units on a scale Standard Deviation 4.93

SECONDARY outcome

Timeframe: From baseline to 24 weeks

Population: Participants with available data

The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. The percentage of participants with an SDAI score ≤3.3 was documented.

Outcome measures

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=143 Participants Participants who received adalimumab treatment
Percentage of Participants Achieving SDAI Remission Baseline, n=131	0.0 percentage of participants
Percentage of Participants Achieving SDAI Remission Week 4, n=123	22.0 percentage of participants
Percentage of Participants Achieving SDAI Remission Week 12, n=103	39.8 percentage of participants
Percentage of Participants Achieving SDAI Remission Week 24, n=85	58.8 percentage of participants

Adverse Events

Participants With High Rheumatoid Arthritis Disease Activity

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=157 participants at risk Participants who received adalimumab treatment
Infections and infestations Pyelonephritis	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Infections and infestations Pneumocystis jiroveci pneumonia	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Cardiac disorders Pericarditis	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.

Other adverse events

Measure	Participants With High Rheumatoid Arthritis Disease Activity n=157 participants at risk Participants who received adalimumab treatment
Infections and infestations Gastroenteritis	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Infections and infestations Herpes zoster	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Infections and infestations Nasopharyngitis	1.3% 2/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Infections and infestations Pneumonia	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Infections and infestations Pulpitis dental	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Infections and infestations Pneumonia bacterial	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Blood and lymphatic system disorders Lymphadenopathy	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Immune system disorders Hypersensitivity	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Metabolism and nutrition disorders Hyperuricaemia	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Psychiatric disorders Dysphoria	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Vascular disorders Hypertension	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Gastrointestinal disorders Nausea	1.9% 3/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Hepatobiliary disorders Liver disorder	1.3% 2/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Skin and subcutaneous tissue disorders Alopecia	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Skin and subcutaneous tissue disorders Pruritus	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Skin and subcutaneous tissue disorders Rash	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
General disorders Chills	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
General disorders Injection site erythema	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
General disorders Injection site reaction	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
General disorders Oedema peripheral	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
General disorders Pyrexia	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
General disorders Unevaluable event	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Alanine aminotransferase increased	2.5% 4/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Aspartate aminotransferase increased	1.3% 2/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Gamma-glutamyltransferase increased	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Liver function test abnormal	2.5% 4/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Platelet count decreased	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations White blood cell count decreased	1.9% 3/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Blood beta-D-glucan increased	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Hepatic enzyme increased	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Hepatic enzyme abnormal	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Investigations Mycobacterium tuberculosis complex test positive	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.
Injury, poisoning and procedural complications Foot fracture	0.64% 1/157 • Treatment-emergent adverse events were collected from the time of informed consent until the last dose of adalimumab, up to 26 weeks.

Additional Information

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