Trial Outcomes & Findings for Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care (NCT NCT01163916)

NCT ID: NCT01163916

Last Updated: 2012-12-07

Results Overview

Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.

• Recruitment status: COMPLETED
• Target enrollment: 252 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2012-12-07

Participant Flow

Participant milestones

Measure	Rheumatoid Arthritis Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Study STARTED	126	35	91
Overall Study Safety Population	125	35	91
Overall Study COMPLETED	96	31	71
Overall Study NOT COMPLETED	30	4	20

Reasons for withdrawal

Measure	Rheumatoid Arthritis Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Overall Study Withdrawal by Subject	2	0	2
Overall Study Adverse Event	2	0	1
Overall Study Lack of Efficacy	2	0	1
Overall Study Other	24	4	16

Baseline Characteristics

Study to Characterize Demographics, Compliance, Tolerability and Safety in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis Prescribed Adalimumab (Humira®) as Part of Routine Clinical Care

Baseline characteristics by cohort

Measure	Rheumatoid Arthritis n=126 Participants Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Total n=252 Participants Total of all reporting groups
Age Continuous	47.0 years STANDARD_DEVIATION 13.7 • n=93 Participants	42.4 years STANDARD_DEVIATION 12.6 • n=4 Participants	36.2 years STANDARD_DEVIATION 10.6 • n=27 Participants	42.5 years STANDARD_DEVIATION 13.4 • n=483 Participants
Sex: Female, Male Female	93 Participants n=93 Participants	18 Participants n=4 Participants	23 Participants n=27 Participants	134 Participants n=483 Participants
Sex: Female, Male Male	33 Participants n=93 Participants	17 Participants n=4 Participants	68 Participants n=27 Participants	118 Participants n=483 Participants
Region of Enrollment Russian Federation	126 participants n=93 Participants	35 participants n=4 Participants	91 participants n=27 Participants	252 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline

Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.

Outcome measures

Measure	Rheumatoid Arthritis n=126 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Characteristics of Patients Prescribed Adalimumab: Education Level Secondary school	21 participants	2 participants	5 participants	—
Characteristics of Patients Prescribed Adalimumab: Education Level Vocational school/college	34 participants	9 participants	26 participants	—
Characteristics of Patients Prescribed Adalimumab: Education Level University degree	64 participants	19 participants	51 participants	—
Characteristics of Patients Prescribed Adalimumab: Education Level Current university student	5 participants	5 participants	8 participants	—
Characteristics of Patients Prescribed Adalimumab: Education Level Other	2 participants	0 participants	1 participants	—

PRIMARY outcome

Timeframe: Baseline

Participants were asked to indicate their occupation at the Baseline visit.

Outcome measures

Measure	Rheumatoid Arthritis n=126 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Characteristics of Patients Prescribed Adalimumab: Occupation Blue collar worker	13 participants	5 participants	10 participants	—
Characteristics of Patients Prescribed Adalimumab: Occupation Civil servant	10 participants	5 participants	12 participants	—
Characteristics of Patients Prescribed Adalimumab: Occupation White collar worker	52 participants	13 participants	38 participants	—
Characteristics of Patients Prescribed Adalimumab: Occupation Self-employed	8 participants	1 participants	9 participants	—
Characteristics of Patients Prescribed Adalimumab: Occupation Student	7 participants	4 participants	4 participants	—
Characteristics of Patients Prescribed Adalimumab: Occupation Retired	21 participants	4 participants	4 participants	—
Characteristics of Patients Prescribed Adalimumab: Occupation Other	15 participants	3 participants	14 participants	—

PRIMARY outcome

Timeframe: Baseline

Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.

Outcome measures

Measure	Rheumatoid Arthritis n=126 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Characteristics of Patients Prescribed Adalimumab: Residence Status Temporary	13 participants	2 participants	3 participants	—
Characteristics of Patients Prescribed Adalimumab: Residence Status Permanent	113 participants	33 participants	88 participants	—

PRIMARY outcome

Timeframe: Baseline

Participants were asked to indicate their marital status at the Baseline visit.

Outcome measures

Measure	Rheumatoid Arthritis n=126 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Characteristics of Patients Prescribed Adalimumab: Marital Status Married	94 participants	24 participants	69 participants	—
Characteristics of Patients Prescribed Adalimumab: Marital Status Single	32 participants	11 participants	21 participants	—
Characteristics of Patients Prescribed Adalimumab: Marital Status Missing	0 participants	0 participants	1 participants	—

PRIMARY outcome

Timeframe: Baseline

Population: Safety set.

Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.

Outcome measures

Measure	Rheumatoid Arthritis n=125 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Characteristics of Patients Prescribed Adalimumab: Disease Severity Mild	0 participants	2 participants	0 participants	—
Characteristics of Patients Prescribed Adalimumab: Disease Severity Moderate	44 participants	14 participants	31 participants	—
Characteristics of Patients Prescribed Adalimumab: Disease Severity Severe	81 participants	19 participants	60 participants	—

PRIMARY outcome

Timeframe: Baseline

Population: Safety set

Duration of disease was defined as the time from diagnosis until study entry.

Outcome measures

Measure	Rheumatoid Arthritis n=125 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Characteristics of Patients Prescribed Adalimumab: Duration of Disease	71.70 months Full Range 81.91 • Interval 0.1 to 370.4	103.50 months Full Range 110.02 • Interval 13.2 to 597.3	50.90 months Full Range 79.47 • Interval 0.0 to 376.3	—

PRIMARY outcome

Timeframe: Baseline and at each follow-up visit (up to a maximum of 18.2 months).

Population: Safety set

Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs [NSAIDs], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.

Outcome measures

Measure	Rheumatoid Arthritis n=125 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment NSAIDs	73 participants	16 participants	72 participants	—
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment Other medications	82 participants	18 participants	65 participants	—
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment Methotrexate	96 participants	23 participants	20 participants	—
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment Corticosteroids	48 participants	9 participants	16 participants	—

SECONDARY outcome

Timeframe: Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.

Population: The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.

At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were "convenient," "inconvenient" and "unable to self-inject."

The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice.

Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization.

Outcome measures

Measure	Rheumatoid Arthritis n=251 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=251 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=251 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing n=251 Participants Participants for whom acceptability data were not available.
Patient's Acceptability of Self-injections Visit 1: 40 mg once a week	0 participants	0 participants	0 participants	0 participants
Patient's Acceptability of Self-injections Visit 2: 40 mg every other week	172 participants	7 participants	63 participants	0 participants
Patient's Acceptability of Self-injections Visit 2: 40 mg once a week	1 participants	0 participants	1 participants	0 participants
Patient's Acceptability of Self-injections Visit 3: 40 mg every other week	177 participants	7 participants	49 participants	0 participants
Patient's Acceptability of Self-injections Visit 3: 40 mg once a week	0 participants	0 participants	0 participants	0 participants
Patient's Acceptability of Self-injections Visit 3: Missing regimen data	4 participants	0 participants	0 participants	0 participants
Patient's Acceptability of Self-injections Visit 4: Missing regimen data	2 participants	0 participants	0 participants	0 participants
Patient's Acceptability of Self-injections Visit 5: 40 mg every other week	137 participants	1 participants	39 participants	0 participants
Patient's Acceptability of Self-injections Visit 5: 40 mg once a week	0 participants	0 participants	0 participants	0 participants
Patient's Acceptability of Self-injections Visit 6: 40 mg every other week	105 participants	1 participants	27 participants	0 participants
Patient's Acceptability of Self-injections Visit 6: Missing regimen data	0 participants	0 participants	0 participants	1 participants
Patient's Acceptability of Self-injections Visit 1: 40 mg every other week	168 participants	10 participants	71 participants	0 participants
Patient's Acceptability of Self-injections Visit 2: Missing regimen data	2 participants	0 participants	0 participants	0 participants
Patient's Acceptability of Self-injections Visit 4: 40 mg every other week	155 participants	3 participants	45 participants	0 participants
Patient's Acceptability of Self-injections Visit 4: 40 mg once a week	0 participants	0 participants	0 participants	0 participants
Patient's Acceptability of Self-injections Visit 5: Missing regimen data	0 participants	0 participants	1 participants	1 participants
Patient's Acceptability of Self-injections Visit 6: 40 mg once a week	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: For the duration of the study (up to a maximum of 18.2 months).

Population: Safety set; the analysis only includes participants with non-missing data.

Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.

Outcome measures

Measure	Rheumatoid Arthritis n=125 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=90 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Percentage of Participants With Missed or Delayed Injections No missed or delayed injections	55.2 percentage of participants	57.1 percentage of participants	56.7 percentage of participants	—
Percentage of Participants With Missed or Delayed Injections One missed or delayed injection	21.6 percentage of participants	11.4 percentage of participants	21.1 percentage of participants	—
Percentage of Participants With Missed or Delayed Injections Two missed or delayed injections	9.6 percentage of participants	20.0 percentage of participants	7.8 percentage of participants	—
Percentage of Participants With Missed or Delayed Injections Three or more missed or delayed injections	13.6 percentage of participants	11.4 percentage of participants	14.4 percentage of participants	—

SECONDARY outcome

Timeframe: For the duration of the study (up to a maximum of 18.2 months).

Population: Safety set.

Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.

Outcome measures

Measure	Rheumatoid Arthritis n=125 Participants Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 Participants Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 Participants Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.	Missing Participants for whom acceptability data were not available.
Duration of Treatment With Adalimumab	52.10 weeks Interval 0.1 to 74.0	52.90 weeks Interval 25.1 to 81.4	52.30 weeks Interval 10.3 to 78.0	—

Adverse Events

Rheumatoid Arthritis

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Psoriatic Arthritis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ankylosing Spondylitis

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rheumatoid Arthritis n=125 participants at risk Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 participants at risk Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 participants at risk Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Infections and infestations Bacteraemia	0.80% 1/125 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	0.00% 0/35 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	0.00% 0/91 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.
Infections and infestations Purulent discharge	0.80% 1/125 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	0.00% 0/35 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	0.00% 0/91 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.
Injury, poisoning and procedural complications Wound necrosis	0.80% 1/125 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	0.00% 0/35 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	0.00% 0/91 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.

Other adverse events

Measure	Rheumatoid Arthritis n=125 participants at risk Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.	Psoriatic Arthritis n=35 participants at risk Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.	Ankylosing Spondylitis n=91 participants at risk Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
Infections and infestations Respiratory tract infection viral	7.2% 9/125 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	0.00% 0/35 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.	8.8% 8/91 • Participants were followed for an average of 12 months with a maximum observation period of 18.2 months.

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER