Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease (NCT NCT02065570)

NCT ID: NCT02065570

Last Updated: 2021-02-18

Results Overview

Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

514 participants

Primary outcome timeframe

Week 4

Results posted on

2021-02-18

Participant Flow

Participants were randomized in a 3:2 ratio at Baseline to receive a higher induction adalimumab regimen or standard induction adalimumab regimen during the double-blind Induction Study. At Week 12, participants were re-randomized in a 1:1 ratio to a double-blind exploratory treatment regimen (adalimumab clinically adjusted \[CA\] regimen or adalimumab therapeutic drug monitoring \[TDM\] regimen).

Participant milestones

Participant milestones
Measure	Induction: Standard Induction Dose Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.	Induction: Higher Induction Dose Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose could be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Induction Study STARTED	206	308	0	0
Induction Study COMPLETED	192	287	0	0
Induction Study NOT COMPLETED	14	21	0	0
Maintenance Study STARTED	0	0	109	109
Maintenance Study COMPLETED	0	0	87	90
Maintenance Study NOT COMPLETED	0	0	22	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Induction: Standard Induction Dose Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.	Induction: Higher Induction Dose Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose could be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Induction Study Adverse Event	5	12	0	0
Induction Study Withdrawal by Subject	2	3	0	0
Induction Study Lost to Follow-up	1	1	0	0
Induction Study Other, Not Specified	6	5	0	0
Maintenance Study Adverse Event	0	0	8	8
Maintenance Study Withdrawal by Subject	0	0	1	4
Maintenance Study Lost to Follow-up	0	0	2	2
Maintenance Study Other, Not Specified	0	0	11	5

Baseline Characteristics

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Total n=514 Participants Total of all reporting groups
Age, Continuous	36.4 years STANDARD_DEVIATION 12.79 • n=99 Participants	36.4 years STANDARD_DEVIATION 13.02 • n=107 Participants	36.4 years STANDARD_DEVIATION 12.92 • n=206 Participants
Sex: Female, Male Female	109 Participants n=99 Participants	158 Participants n=107 Participants	267 Participants n=206 Participants
Sex: Female, Male Male	97 Participants n=99 Participants	150 Participants n=107 Participants	247 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants	10 Participants n=107 Participants	15 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	201 Participants n=99 Participants	298 Participants n=107 Participants	499 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	18 Participants n=99 Participants	11 Participants n=107 Participants	29 Participants n=206 Participants
Race (NIH/OMB) White	182 Participants n=99 Participants	288 Participants n=107 Participants	470 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants Who Achieved Clinical Remission at Week 4	43.7 percentage of participants	43.5 percentage of participants	—	—

PRIMARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Endoscopic response was scored using the Simplified Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score \> 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Endoscopic Response at Week 12	39.3 percentage of participants	42.9 percentage of participants	—	—

PRIMARY outcome

Timeframe: From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).

Population: Safety Set: all participants who received at least one injection of study drug.

Adverse event (AE): any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs: any event that began or worsened in severity after the first dose of study drug in the induction or maintenance study. Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug-related.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen n=109 Participants Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen n=109 Participants At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE	133 Participants	185 Participants	77 Participants	76 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAE w/reasonable possibility of being related to study drug	54 Participants	75 Participants	29 Participants	33 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any SAE	10 Participants	14 Participants	5 Participants	7 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any severe TEAE	13 Participants	17 Participants	7 Participants	6 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE leading to discontinuation of study drug	8 Participants	13 Participants	8 Participants	9 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Any TEAE leading to death	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Deaths	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 4 and Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12	35.0 percentage of participants	39.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Clinical response was scored using CDAI, which assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline. Endoscopic response was scored using the SES-CD, which evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score \>50% from Baseline (or for Baseline SES-CD of 4, at least a 2-point reduction from Baseline) at Week 12.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12	20.4 percentage of participants	22.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Clinical Remission at Week 12	51.5 percentage of participants	62.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Participants taking corticosteroids at Baseline.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=100 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=155 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline	48.0 percentage of participants	52.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Endoscopic Remission at Week 12	26.2 percentage of participants	28.6 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Intent to Treat Population: all participants who were randomized. Participants with a baseline and Week 4 assessment. Observed cases.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=152 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=252 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Change From Baseline in Fecal Calprotectin Level at Week 4	-1045.7 µg/g Standard Deviation 1648.51	-1157.0 µg/g Standard Deviation 2000.69	—	—

SECONDARY outcome

Timeframe: Week 4

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4	27.7 percentage of participants	32.5 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 4

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4	11.2 percentage of participants	14.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at Week 12	7.3 percentage of participants	11.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 \[none\] to 3 \[very large\]; ulcerated surface ranging from 0 \[none\] to 3 \[\>30%\]; affected surface ranging from 0 \[none\] to 3 \[\>75%\], and narrowing ranging from 0 \[none\] to 3 \[cannot be passed\]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants Who Achieved an SES-CD ≤ 2 at Week 12	16.0 percentage of participants	20.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 4

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Clinical response was scored using CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from baseline.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Clinical Response at Week 4	70.9 percentage of participants	74.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Clinical response was scored using CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants With Clinical Response at Week 12	74.8 percentage of participants	83.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 4

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 8.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at Week 4	71.4 percentage of participants	74.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12	73.3 percentage of participants	76.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 12

Population: Intent to Treat Population: all participants who were randomized. Non-responder imputation.

The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.

Outcome measures

Outcome measures
Measure	Induction: Standard Induction Dose n=206 Participants Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 Participants Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Monitoring (TDM) Regimen At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 12	68.4 percentage of participants	76.0 percentage of participants	—	—

Adverse Events

Induction: Standard Induction Dose

Serious events: 10 serious events

Other events: 54 other events

Deaths: 0 deaths

Induction: Higher Induction Dose

Serious events: 14 serious events

Other events: 58 other events

Deaths: 0 deaths

Maintenance: Clinically Adjusted (CA) Regimen

Serious events: 5 serious events

Other events: 41 other events

Deaths: 0 deaths

Maintenance: Therapeutic Drug Management (TDM) Regimen

Serious events: 7 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Induction: Standard Induction Dose n=206 participants at risk Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg eow starting at Week 4 through Week 12.	Induction: Higher Induction Dose n=308 participants at risk Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.	Maintenance: Clinically Adjusted (CA) Regimen n=109 participants at risk Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to ew starting as early as Week 14 and up to Week 54 based on CDAI or hs-CRP values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.	Maintenance: Therapeutic Drug Management (TDM) Regimen n=109 participants at risk At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM are determined by protocol-established dose adjustment criteria. Doses are determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 receive 40 mg ew.
Gastrointestinal disorders CROHN'S DISEASE	5.8% 12/206 • Number of events 14 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	4.5% 14/308 • Number of events 15 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	14.7% 16/109 • Number of events 20 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	13.8% 15/109 • Number of events 17 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Gastrointestinal disorders DIARRHOEA	1.5% 3/206 • Number of events 3 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	0.65% 2/308 • Number of events 2 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	5.5% 6/109 • Number of events 7 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	3.7% 4/109 • Number of events 4 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Gastrointestinal disorders NAUSEA	7.3% 15/206 • Number of events 17 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	2.9% 9/308 • Number of events 10 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	4.6% 5/109 • Number of events 7 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	2.8% 3/109 • Number of events 3 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Infections and infestations NASOPHARYNGITIS	4.4% 9/206 • Number of events 11 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	6.2% 19/308 • Number of events 21 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	13.8% 15/109 • Number of events 15 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	9.2% 10/109 • Number of events 12 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	7.8% 16/206 • Number of events 19 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	3.2% 10/308 • Number of events 10 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	7.3% 8/109 • Number of events 8 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	3.7% 4/109 • Number of events 5 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Nervous system disorders DIZZINESS	5.3% 11/206 • Number of events 13 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	0.65% 2/308 • Number of events 2 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	0.00% 0/109 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	0.00% 0/109 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Nervous system disorders HEADACHE	8.7% 18/206 • Number of events 24 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	5.5% 17/308 • Number of events 19 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	8.3% 9/109 • Number of events 9 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).	7.3% 8/109 • Number of events 18 • From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER